Johnson & Johnson - Custom Search safety

Johnson & Johnson companies are equal opportunity employers.

Manager, Environment Health & Safety (EHS) - Rochester, NY-6801130303

Description

Medical Devices & Diagnostics Global Services, LLC., is recruiting for a Environmental Health & Safety Manager (EHS Manager) to support the Ortho-Clinical Diagnostics (OCD) franchise. The ideal candidate will be located in Rochester, New York.

Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D SC supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.

Ortho Clinical Diagnostics serves the transfusion medicine community and laboratories around the world. We're a leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early, before they put lives at risk. Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life.

The EHS Manager will ensure that the OCD Rochester, New York operation is in compliance with federal, state, and local EHS regulations as well as Johnson & Johnson EHS Standards. This individual will determine and adjust EHS Strategy and Policy for the site, in alignment with the MD&D Strategy and Policy, MD&D Strategic Imperatives along with OCD Franchise and site imperatives. This individual will develop EHS objectives for the site - auditing, analyzing, documenting, and reporting on their implementation. The EHS Manager will partner with site management to develop management action plans to address deficiencies in EHS program components. This individual will conduct studies and formulate strategic plans involving the aspects and impacts of plant production and laboratory operations, working towards continuous improvement of OCD EHS programs. In addition, this individual will select and develop competent staff and provide adequate coaching and counseling to direct reports; develop and monitor progress on employee development plans; develop recommendations as part of the succession planning, appraisal, and salary planning process. The EHS Manager will lead staff to develop and implement appropriate EHS policies, programs and training to address corporate and regulatory requirements. This individual will develop and implement EHS training strategy for the overall site, and EHS personnel. This individual will report EHS progress to management via dashboards and reports. The EHS Manager will maintain local ISO certifications by ensuring that site EHS management systems aligned with ISO standards are implemented and evaluated for effectiveness. In addition, this individual will manage site level EHS budget.

J2W:LI

Qualifications

A Bachelor Degree in Safety or Industrial Hygiene, Environmental Engineering/Science, Safety Engineering/Science, Chemical Engineering or related EHS field is required. A minimum of six years of meaningful EHS experience is required, preferably in an FDA-regulated environment. Experience in engineering and management in diverse EHS areas including but not limited to Occupational Safety and Health, machine safety, ergonomics, industrial hygiene, chemical handling is highly desirable. Must have technical/working knowledge of federal and state regulations and local requirements, as well as international standards (ex. ISO 14001; OHSAS 18001).

Demonstrated leadership abilities as well as proven track record of managing and developing professional-level talent are required. Demonstrated project management skills are required as well as computer literacy in standard office software programs. Good interpersonal skills combined with excellent oral and written communications and classroom instructor skills are required.

This position requires 10% domestic and possibly international travel and is based in Rochester, NY.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

J2W: LI

Primary Location:North America-United States-New York-Rochester
Organization: OCD Inc. (6118)

Job: Environmental Health & Safety
Relocation: Eligible
No

Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson & Johnson companies are equal opportunity employers.

Director, QA Complaint Handling and Safety Surveillance-5944130417

Description

DePuy Synthes Companies of Johnson & Johnson is seeking a Director, QA Complaint Handling and Safety Surveillance in West Chester, PA.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

The Director, QA Complaint Handling and Safety Surveillance will hire and organize department of medical and technical professionals such that we are able to meet all safety, regulatory and quality requirements in an efficient, process-oriented manner. This individual will develop talent for future positions at DePuy Synthes and/or J&J. He/she will implement automated systems that can obtain data in a consistent manner, allow appropriate and trending for signal detection, and provide reports to management on a monthly basis regarding trends. This individual will ensure metrics cover all patient issues for concomitant medical treatment as well as technical overview of complaints. He/she will ensure systems are current, validated and implemented on a worldwide basis. The Director, QA Complaint Handling and Safety Surveillance will manage a team to include: technical complaint group, medical safety surveillance group, clinical reports/complaints. He/she will develop and report critical monthly metrics. This individual will work closely with Medical/Clinical Group to ensure consistency in medical evaluations, Quality Board decisions and overall Safety evaluations of product. He/she will provide feedback to Development organization on potential areas for improvement for DePuy Synthes product. The Director, QA Complaint Handling and Safety Surveillance will develop and implement program to review literature for technical and medical review of DePuy Synthes and competitive product. He/she will develop and implement risk assessment for safety and technical evaluations.

Qualifications

A minimum of a Bachelors Degree is required. Candidates must have a minimum of 15 years experience in a regulated industry or possess a Masters Degree with a minimum of 10 years experience in a regulated industry. A minimum of 5 years of complaint handling experience in medical devices is required. Previous people management experience is required. Knowledge of the medical device marketplace usually associated with some successful experience in one or more of the following is required: marketing, sales, customer service or technical applications. Experience in orthopaedics is preferred. Understanding of health hazard evaluations is required. Experience interacting with the FDA required. Excellent communications and analytical skills are required. Working knowledge of Microsoft Office, Excel, Power Point, and Access is required.

This position will be based in West Chester, PA and will require up to 25% travel, including potential international.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

J2W:LI

Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)

Job: Quality Assurance
Travel:Yes, 25% of the time

Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson & Johnson companies are equal opportunity employers.

Quality Engineer - Post Market Surveillance Safety Investigation (PSI)-5236130321

Description

DePuy Synthes Companies of Johnson & Johnson, is currently recruiting for a Quality Engineer - Post Market Surveillance Safety Investigation (PSI) in Warsaw, IN.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

The Quality Engineer - PSI's role will perform post-market safety and surveillance activities including trend analyses, signal assessments and investigations. He/she will execute the PMS process with a primary focus on signal assessment and detailed investigations of potential Safety Issues and Quality Trend Events. This individual will utilize the signal analysis and detection data generated by the analytics team to assess trends/issues and perform detailed investigations to confirm the identified event.

The Quality Engineer - PSI will evaluate Signal Analysis/Detection Data, and interface with the PMS data analytics team to review signal analysis and detection data focusing on trends, triggers and control limits in PMS data that represent a potential Safety Issue/Product Quality Event. He/she will also be responsible for evaluating potential Safety Issues/Product Quality Events against all known PMS Data sets with the intent of confirming the issues/event. This individual will lead Signal Assessment Investigations and perform issue/event investigations to understand root causes, risk and their impact.

The Quality Engineer - PSI will also interface with key business partners including R&D, Operations, Medical and Marketing to ensure a thorough investigation is completed; investigations can include user interviews and customer visits to ensure rapid response to field safety issues. Depending upon the nature of the identified safety issue/product quality event, the Quality Engineer - PSI will be the key interface with the Product Escalation group to ensure all events are escalated in a timely manner and per procedure.

Qualifications

A minimum Bachelors Degree in an Engineering or technical discipline is required. A Master's degree is a plus. A minimum of 2 years experience in a related field is required. Excellent problem solving, decision-making, and root cause analysis skills is required. Experience with Post Market Surveillance activities is preferred. Previous experience in a medical device, healthcare, or a highly regulated industry is also required. Proficiency with the Microsoft Office Suite is required. Strong working knowledge of the QSR and/or ISO quality requirements is strongly preferred. Excellent written and oral communication skills are required. The ability to collaborate with business partners at all levels across multiple functional groups in an environment that embraces teamwork and risk-based decision making is required. Knowledge of process and design excellence tools and Green or Black Belt training are a plus.

This position may require up to 10% domestic travel. This position will be based in Warsaw, IN and does not offer relocation benefits.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

J2W:LI

Primary Location:North America-United States-Indiana-Warsaw
Organization: Depuy Products Inc. (6030)

Job: Quality (Eng)
Relocation: Eligible
No
Travel:Yes, 10% of the time

Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Regulatory Affairs Specialist-Guangzhou Bioseal Plant-000008D4

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The employee of this position will sign labor contract witl Guangzhou Bioseal Biotech co., Ltd.

• Develop general EHS requirements and programs in a Biopharmaceutical company
• Drive an comprehensive program for achieving compliance with local China regulatory and Johnson & Johnson requirements while meeting business constraints of the business location being supported;
• Implement requirements internally and work with regulatory agencies to obtain necessary licenses and permits
• Manager regulatory compliance assessments
• Extrapolate general guidance documents to the specifics of the business location;
• Manage multiple concurrent task and deadlines, developed innovative solutions to problems, partner well with associates at all levels and have the leadership skills to lead projects and teams;
• Manage projects requiring advanced knowledge of EH&S related practices from identification of potential risk to analysis of the level of risk to the implementation of appropriate control measures;
• Provides input to various reports and record keeping J&J systems;
• Develop corrective actions in a resourceful and creative manner while using existing resources to address gaps in program components;
• Demonstrate independent judgment and problem-solving skills.

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• Minimum of a Bachelor Degree is required, preferably in Safety Engineering/ Environmental Science.
• A minimum of 10 years industry experience, and a minimum of 7 years EH&S related experience is required for this role. .
• The ideal individual must be skilled in Microsoft Office applications.
• Experience working with EH&S data reporting and tracking systems is a plus.
• Because position will interface with all levels of management, excellent written and verbal communication skills are required.
• Safety and Environmental management systems, including ISO 14001 and OHSAS 18001, along with technical knowledge of occupational safety, industrial hygiene, ergonomic and/or environmental compliance program components is required.
• Certification or demonstrated progress towards certification, i.e., Associate/Certified Safety Professional is preferred but not required.

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Local Safety Officer-00000CIR

Description

Company

The Johnson & Johnson Family of Companies is comprised of more than 250 operating companies in 60 countries. Our companies develop and market products in three business segments: Consumer, Medical Devices & Diagnostics and Pharmaceuticals. At least a billion people around the world are touched each day by what we do.

Johnson & Johnson has consistently received awards from prestigious organizations. Most recent recognitions include 2nd Rank in Barron's list of World's Most Respected Companies in 2010 and 4th Rank in Fortune's list of World's Most Admired Companies in 2010.

Janssen Pharmaceutica is a division of Johnson & Johnson and is actively engaged in addressing the most critical needs of patients around the worlds through 5 major therapeutic areas: Oncology, Central Nervous System, Pain, Infectious Diseases and Biological & Immunology. Janssen has been in the Philippines since 1982 and has launched different products that have led in the therapeutic areas they participate in. It can be extremely satisfying to work with physicians in delivering these healthcare solutions, both in developed and emerging markets where they can bring a powerful measure of hope to people who suffer from the ravages of their conditions.

Position

Local Safety Officer, Medical Department - Janssen Pharmaceutica

(Based in Manila, Philippines)

Principal Responsibilities

-
Set-up and maintain a pharmacovigilance system that ensures information about all suspected adverse reactions are collected, evaluated and collated.

- Write local pharmacovigilance SOPs which are consistent with global SOPs and local regulatory guidelines.
- Ensure that all adverse events received as well as periodic safety update data are reported to Benefit Risk Management and, if needed, to the Bureau of Food and Drugs according to relevant timelines.
- Carry-out an initial medical review and assessment of reported adverse events.
- Maintain a file (both digital and hard copy) of local drug safety data that could be quickly and efficiently accessed as needed.
- Conduct adverse event reporting training among all employees of J&J.
- Represent the company as a single point of contact to represent the company in safety-related issues before the regulatory agency, the media and other relevant public audiences.
- Provide technical and strategic safety input into the management team.

Key Result Areas

Pharmacovigilance System

- Proportion of identified needed SOPs which are actually written.
- Presence of an updated adverse event report database and hard-copy filing system that could be efficiently accessed as needed.

Adverse Event Reporting

- Proportion of adverse event reports received that were transmitted to BRM and BFAD.
- Proportion of adverse event reports received that were transmitted to BRM and BFAD on time.
- Proportion of adverse event reports received on which preliminary medical review and assessment was carried out.

Training

- Proportion of identified needed pharmacovigilance trainings which were actually conducted.

Company Representation

- Number of occasions when the company needed drug safety representation of relevant audiences which were properly attended.

Management Support

- Number of Occasions when technical and strategic management team input was needed which were properly attended.

Qualifications

- Bachelor Degree in Life or Health Sciences, Masters Degree in a related field or Medical Degree preferred
- Computer literate especially in database programs, experience in setting up databases preferred
- Effective oral and written communication skills, experience in writing standard operating procedures preferred
- Exceptional leadership ability and people skills, especially in getting the entire organization to comply with regulations and guidelines
- Previous experience as local safety officer or similar role preferred
- Willing to work during holidays and weekends
- GCP trained

Primary Location:Asia Pacific-Philippines-National Capital-Manila
Organization: Johnson & Johnson (Philippines) Inc. (8385)
Job Function: Drug & Product Safety Operations

Pharmacovigilance Physician or Scientist-00000CMA

Description

Crucell is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. Crucell focuses on the research & development, production and marketing of vaccines and antibodies against infectious disease worldwide. Currently we are combating twelve major infectious diseases with our range of marketed vaccines in the paediatric, travel and endemic and respiratory fields.

Position Summary

At the core to this position are the continuous surveillance, monitoring and management of the benefits and risks of assigned Crucell's marketed and investigational products. The role's holder contributes to the maintenance and implementation of quality systems and procedures for the detection, assessment, understanding, and prevention of adverse effects related to Crucell products to assure compliance with company standards and regulatory requirements.

Principal Responsibilities

- Maintains oversight of benefit and risk balance for assigned products in clinical development and in postmarketing settings.
- Responsible to perform routine signal detection activities and signal tracking as well as Health Hazard Evaluations for own products.
- As SMT Chair, act as primary liaison for assigned products between benefit and risk management teams (mainly SMTs) and internal customers including Janssen Global Safety Council (GSC).
- Escalates significant safety issues to GSC.
- Develops and maintain Reference Safety Information (e.g. Company Core Safety Information and Development Company Core Safety Information) for assigned products.
- Leads writing of PBERS, DSURs and other aggregate safety reports, as well as RMPs for own products.
- Leads responses to safety-related Health Authorities queries.
- Performs and reviews analyses drawn from information provided by healthcare providers and consumers on the adverse effects of assigned medicinal products with focus on identifying new information on hazards with Crucell product
- Prepares, writes and reviews medical safety sections of clinical trials protocols, investigators brochures, clinical study reports and other medical safety documentation
- Performs medical review, validation, assessment, compilation of PV comments where applicable, for individual case safety reports including safety reports from clinical trials. Triggers quality investigations where applicable in accordance with the Company standard procedures.
- Contributes to global quality assurance and optimization of PV processes. Participates to internal PV audits and external PV or product-specific inspections and to responses and establishment of corrective actions as warranted.
- Maintains own professional training up to date through self-learning, participation to external conferences and internal Company training plans

Qualifications

Eductaion & Experience Requirements

Doctor of Medicine with a broad experience in the medical field and at least 3 - 5 years of significant experience in pharmacovigilance on a global level.

Experience and professional / personal profile

- Profound knowledge and understanding of Pharmacovigilance, immunology, clinical development, postmarketing surveillance and safety data analyses.
- Good knowledge of the regulatory framework, pharmacovigilance regulations and methodologies.
- Knowledge and understanding of process-driven activities, experience in managing compliance with internal SOPs, Working Procedures, and external regulations
- Business fluent in English
- Strong problem solving and communication skills
- Ability to work in a small team in a global environment, to work goal-oriented and to multi-task, with strong interpersonal and leadership skills

We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms. Have we piqued your interest? Please apply today, we look forward to receiving your application.

AD CODE: J2W: JOBSCH

Primary Location:Europe/Middle East/Africa-Switzerland-Berne-Bern
Other Locations:Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Crucell Switzerland AG (8851)
Job Function: Pharmacovigilance

Local Safety Specialist Xi'an-00000CNB

Description

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Qualifications

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Primary Location:Asia Pacific-China-Shaanxi-Xi'an
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function: Drug & Product Safety Science

Local Safety Specialist Beijing-00000CF0

Description

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Qualifications

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Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function: Drug & Product Safety Science

Johnson & Johnson companies are equal opportunity employers.

Assoc Director Risk Management-4587130516

Description

Johnson & Johnson Consumer Products Company, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Risk Management located in Skillman, NJ.

Johnson & Johnson Family of Consumer Companies develops and markets OTC drugs, nutritional products, baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S® Baby and BAND-AID® Brand, TYLENOL® and MOTRIN ®products, ZYRTEC® and BENADRYL® allergy medicines, NEUTROGENA®, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR®.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Associate Director Risk Management (ADRM) is responsible for the review and analysis of any safety-associated issues that are or might be due to product quality issues, for the analysis of safety surveillance observations, and the response to safety inquiries from the Medical Safety Officer and internal and external authorities using internal and external post-marketing databases including AERS and MAUDE, the medical literature and exposure information for a wide range of cosmetic, OTC and medical device Personal Consumer products. The ADRM will report analysis results in support of signal detection and triage, health hazard / risk evaluations, risk management plans, regulatory submissions, label justification, and the assessment of safety profiles for all products in assigned franchises. In this role, the ADRM has a primary responsibility and accountability for the planning, tracking, archiving, quality and technical content of surveillance and aggregate and ad-hoc safety assessment reports. In addition, the ADRM may be expected to develop content of Risk Management Plans for technical documents; summarize ongoing projects for the global safety committee; create project summaries for documentation purposes; and, may assist in the management of safety issues from development through post-marketing.

The Associate Director Risk Management (ADRM) contributes to safety report strategy and planning. (S)he initiates searches of post-marketing databases and related product vigilance sources, customer response systems and Health Authority databases. This individual initiates searches of post-marketing databases and related product vigilance sources, customer response systems and Health Authority databases. (S)he prepares, drafts and writes scheduled and ad-hoc regulatory and aggregate reports, labeling, core data sheet updates and related documents. (S)he prepares safety documentation used in medical safety assessments, health hazard / risk evaluations, risk management plans, safety responses and other regulatory submissions. This person will represent the Medical Safety Officer as a participant in quality and safety committees to assist in safety issue management and signal escalation.

The Associate Director Risk Management (ADRM) conducts data compilation with Safety and QA input; interprets risk of product failure through design or manufacturing issue. (S)he conducts or directs searches of medical textbooks, reference sources (e.g. USP, CDC, AERS, MAUDE), and scientific literature. S(he) analyzes and interprets aggregate / tabulated safety surveillance data, lot trend and exposure information. S(he) identifies the need for, conducts, and summarizes case series reviews . (S)he evaluates and summarizes product efficacy data used in risk management plans or related documents.

Qualifications

This position requires a Bachelor degree in a technical, scientific, or related/equivalent discipline. A minimum of five (5) years of clinical development safety and/or post-marketing safety experience is required. A minimum of 5 years experience in management of broad-ranging product safety and development activities with decision-making responsibilities is required. Expert-level ability to search, analyze, interpret and clearly present safety, scientific and clinical data in written format is required. Proficiency in MS Outlook, Word, and Excel is desired. Excellent verbal and written communication skills are required. An advanced degree (e.g. M.D.,MPH, PharmD, MA or experience) in life sciences, Quality Assurance or health-care discipline is desired. Expertise and experience in Women's Health, dermatology, pharmacology, epidemiology, medical devices and/or decision sciences is desired. Prior team-managerial experience is desired. Medical writing experience is desired. Consumer Health experience is desired. There is a clear expectation that this person will be able to manage a flexible work schedule to accommodate off-hours meeting times is required. This position is located in Skillman, NJ. There is less than 10% domestic and /or international travel that is required.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)

Job: Pharmacovigilance

Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Local Safety Officer-000009HR

Description

Build Your Career with Janssen-Cilag

Janssen-Cilag is one of the world's most comprehensive and broadly based healthcare companies under Johnson & Johnson. We engage in the discovery, manufacturing and marketing of innovative products to improve people's health and quality of life. At Janssen, you'll be working with one of the world's leading research-based pharmaceutical companies. You will personally contribute to improving the health and quality of life of patients and their nearest and dearest through innovative products, information and services.

Why work here?

You'll thrive in our exciting and dynamic corporate culture, constantly seeking new challenges, making your own independent contributions to the company's success. In the cooperative and open climate that prevails at Janssen, you have the best chance for an attractive and long-term professional future. We are now providing job opportunities and career development for qualified candidates in the following position:

Local Safety Officer

Business Sector: Pharmaceutical

Job Responsibilities
Reporting to the Medical Affairs Director, the LSO is responsible for ensuring Pharmacovigilance inspection readiness at the Operating company level at all times.

- Maintain overall responsibility for the coordination of safety reporting requirements, as required for Marketing Authorization holders (MAH). Manage and maintain active involvement in day-to-day AE reporting. Key responsibilities include collection, review and reporting of adverse events (AEs), Adverse Events combined with product quality complaints (AE+PQCs) and pregnancy reports, obtained through the following sources: spontaneous, solicited, clinical trials, related activities, local Competent Authorities and all other potential sources. Detect and report AEs from Local Scientific Literature. Track AE cases and perform case follow-ups as needed. Undertake site visits for follow-up of local cases of special interest, as appropriate. Conduct initial quality review and assessment of local individual cases. Perform regular reconciliation activities as required by company procedures and local regulations. Ensure an effective system in place for 24-hour coverage.
- Ensure implementation and compliance with global, regional and local procedural documents applicable to Pharmacovigilance. Accountable internally for ensuring that the Local Operating Company meets procedure defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
- Accountable for local operating company compliance monitoring for submissions to Competent Authorities (HAs). Reconcile compliance data provided and take appropriate corrective actions as defined by company policies and procedures.
- Collaborate with local Regulatory group for review of Aggregate Safety Reports as appropriate and ensure timely submission according to local regulations.
- Safety oversight of clinical projects conducted in the territory. Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols to ensure appropriate safety reporting to Competent Authorities, as required.
- Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities. Inform the appropriate global and regional groups ( i.e. QPPV office and regional heads) of any changes to local laws and regulations regarding Pharmacovigilance.
- Provide support for Third Party Agreements with PV implications. Ensure the PV agreement is implemented locally, as appropriate (this includes in/out license products).
- Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the Local Competent Authority to the appropriate global and regional groups (i.e. QPPV office and regional heads) as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address/respond the question. This may include local, regional and/or global expertise.
- Where applicable, support the Qualified Person (QP) for PV to provide safety-related regulatory communication (e.g., response to request for information from Local CA), including the provision of information about the volume of sales or prescription, as appropriate.
- Ensure proper training on drug safety reporting responsibilities of Local Operating Company personnel and maintenance of awareness of drug safety reporting in general.
- Take appropriate measures to ensure that relevant safety information is available to Health Care Professionals in timely manner, if applicable. This activity may be delegated to the local Regulatory Affairs department or another appropriate department as required, as appropriate.
- In collaboration with the Medical Affairs department provide reports to the Health Authority on Post Authorization Safety Studies (PASS), as appropriate.
- Take the appropriate actions for the implementation of urgent safety restrictions, if required.
- Participate in Issue Management teams as required.

Qualifications

- Bachelor's or Master's degree of Pharmaceutical science or Medical Science
- Minimum of 2 -5 years experience in hospital pharmacy or drug safety unit in Pharmaceutical industry
- Audit experience in drug safety is preferred
- Good command of Thai and English in speaking, reading, and writing
- Knowledge in Drug Safety /Clinical Pharmacy
- Well documentation & record management

How to Apply

If you possess what we are looking for, please logon to our careers website: www.careers.jnj.com Search by country 'Thailand' or by requisition number 000009HR and apply by January 31, 2013. All applications must come through the portal.

Primary Location:Asia Pacific-Thailand-Bangkok-Bangkok
Organization: Janssen-Cilag Ltd (7335)
Relocation: Eligible
No
Job Function: Drug & Product Safety Operations

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Johnson & Johnson companies are equal opportunity employers.

PRODUCT SURVEILLANCE SCIENTIST-5012130405

Description

Johnson & Johnson Consumer Products Company, a member of the Johnson & Johnson family of companies, is recruiting for a Product Surveillance Scientist.

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S® Baby and BAND-AID® Brand, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR® and NEUTROGENA.

Under the direction of the Associate Director, Monograph Drugs, Medical Devices and Cosmetics (MDC) Safety Surveillance in the Office of Consumer Medical Safety (OCMS) of the Johnson & Johnson Consumer Companies (JJCC), the Product Surveillance Scientist (PSS) has a primary responsibility and accountability for creating post-marketing safety datasets, performing epidemiological analyses, and contributing to the writing of safety surveillance reports for a wide range of consumer and personal products. The PSS will work in close collaboration with surveillance physicians who will provide the complementary clinical review and medical assessment of these reports; with safety informatics and analytics leadership to test and implement enhanced surveillance systems capabilities; and with project management to ensure the compliance, timeliness and quality of deliverables.

The PSS will have the necessary education and experience to (1) understand the scientific basis and related safety consequences of consumer and personal products; and (2) independently execute epidemiological data management, analysis and reporting. Additionally, the PSS has demonstrated (3) cross-functionally cooperative and collaborative behavior in a global working environment; (4) the breadth and depth of experience to actively contribute to the design, development and implementation of new safety surveillance methods and systems; and (5) the insight and flexibility to seamlessly align with evolving business needs and action plans by proactively assisting management in achieving best in class deliverables.

Tasks and activities that are expected to be within the current core expertise of the PSS include the extraction of post-marketing safety data from internal and external safety databases; the evaluation of pharmacologic and epidemiologic literature; the combination of source data into analysis datasets; the categorization, coding, parsing, text searching and other actions needed to enable scrutiny of large amounts of data; the planning and implementation of epidemiological analyses; and the scientific writing of safety surveillance reports.

Qualifications

A minimum of a Bachelors Degree in life sciences or a health-care discipline, or equivalent professional experience, is required for this role, as is a minimum of three (3) years of post-marketing safety and/or epidemiology experience. An advanced degree (e.g. MPH, PharmD) in life sciences or health-care discipline is preferred.

Additional requirements for this role include: knowledge of principles of drug safety, specifically case series analysis and aggregate reporting; expert-level ability to search, analyze, interpret and clearly present safety, scientific and clinical data in written format; and expertise in at least one of the following: pharmacology, epidemiology, biostatistics and/or decision sciences.

Recent hands-on experience as lead scientist or in a project or program management role is preferred as is experience as an author on complex aggregate safety reports.

Candidates must possess advanced-level skills in MS Outlook and Word, expert level skills in MS Excel and have excellent verbal and written communication skills.

This position may have up to 10% travel and be based in either Ft. Washington, PA or Horsham, PA.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States-Pennsylvania-Fort Washington
Organization: Johnson & Johnson Consumer Inc. (6071)
Job Function: Drug & Product Safety Operations

Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

PV Manager-00000ATO

Description

1. In compliance with local regulations and company requirement, make medical review of all reported study SAE and marketed AEs

a) Ensure all received initial/follow up AE/SAEs timely reported to HA, GMS as well as the third partner according to the requirement of regulations, policies and PV agreements.

b) Ensure follow up the related AEs and report the additional information to HA, GMS and third partner according to the timeline.

2. Perform the medical assessment and involve in product risk management activities

a) Evaluate, identify, analyze potential the drug safety issue and concerns and may well interpret to the stakeholders

b) Make labeling safety review and recommendation to project team

c) Report the risk summary and assessment to the line manager or PV director if needed, lead, finalize and follow up the product risk management process and make proper drug safety recommendation or solution both from technical level and strategic business perspective.

3. As a liaison/point of contact, coordinate and work with all pertinent functions/department, support/execute safety strategy and plan on particular drug development stage

4. Be responsible for AEPQC training to external and internal stakeholders

a) Organize, perform and check the all AE PQC trainings (PV knowledge, product knowledge, regulations, guidelines, SOPs and WIs)

b) Organize, provide and perform the AE/PQC training for all XJP employees, new comers in AE reporting orientation by the different approaches

c) Be responsible for providing the AEPQC training to the external and support PV related inspection and CAPA follow up.

5. Provide safety expertise in local/regional medical safety culture, healthcare delivery system, and practice, and liaison with external vender/ research unit as needed to make sure well implementation of China R&D drug safety strategy

6. Support department head/line manager to identify areas of unmet safety related needs as regards local specifics (for e.g. China population-specific etc)

7. Support department head/line manager to identify areas of risk (for the PV system, policy, product, etc) due to heterogeneity of approaches

8. Provide assistance to safety department head in follow up of key safety issues arising, assistant in gather data, interpreting local medical practice; Be responsible for providing assistance in safety regulatory applications and product life cycle management and in the management of key stakeholders relationship with scientific safety knowledge

9. Provide technical support in safety information handling and product information management, and solve complexity information issues with standard Q&A, work with business partner to manage potential crisis related to product safety

Qualifications

Technical Skill Requirement:

1. Understanding of pharmacovigilance internal and external requirement and environment including scientific, methodological and regulatory aspects

2. Relevant drug safety knowledge and experience at least 2-3 years

3. Documentation management experience

4. Effectively communicating timeline, resource and other issues that have e.g. regulatory compliance

5. Understanding ICH/GCP and PV scientific basis for therapeutic or drug induced diseases. Effective interactions with key subject matter experts.

6. Experience in handling product information, database migration or generating/maintain/updating standard Q&A for product information

Qualifications:

1. Degree/Advanced degree in clinical medicine or pharmacy.

2. Drug safety experiences in PV or clinical research or drug development in international pharmaceutical companies at least for 2-3 years

3. Good problem solving and decision making skill

4. Strong interpersonal skills, with a demonstrated ability to foster team work

5. Ability to manage discussions and decision making

6. Excellent communication, conflict management and negotiation skills

7. Good oral and written English/Chinese communication skill

8. Opening, optimistic and easy going personality

9. Good computer application skills.

Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)

Job: Drug & Product Safety Science

Johnson & Johnson companies are equal opportunity employers.

Global Medical Safety Physician, Cardiovascular & Metabolism, Director-3724120828

Description

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Global Medical Safety Physician, Cardiovascular & Metabolism, Director. This position can is based in Raritan, NJ.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Global Medical Safety (GMS) Physician, Infectious Disease, will report to and assist the GMS Therapeutic Area (TA) Head in the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. The GMS Physician will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the TA. The GMS Physician will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, Chief Safety Officer (CSO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the GMS physician will also contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Johnson & Johnson pharmaceutical products.

Principal responsibilities for the GMS Physician include: provide medical expertise to the GMS TA and provide medical oversight to non-physician GMS staff, provide end-to-end (Phase 1 through product life cycle) safety support and surveillance; chair a multidisciplinary Safety Management Teams (SMT) for assigned products whose responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)), as well as other activities related to managing the safety profile of assigned products; participate on TA Clinical Development Teams (CDTs) and Clinical Teams (CTs) as deemed necessary by the TA Safety Head; present medical safety and risk management evaluations as necessary to the CSO, the GMS Senior Leadership Team, and the Global Safety Council; provide input and review to key regulatory or clinical documents as appropriate, to ensure these key safety documents are of high medical and scientific quality; work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues; assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management; and participate on due diligence teams to evaluate Licensing & Acquisition opportunities.

Qualifications

An MD (or equivalent medical degree) is required. A Board Certification (or relevant national qualifications ex-US) in a relevant medical discipline is preferred. At least 5 years of post-residency/fellowship experience in clinical practice, academia, clinical research, or drug safety from the Pharmaceutical, Biotech or relevant industry experience is required, as is at least 2 years of post marketing safety or related industry experience, including experience preparing PSURs.

Also required and essential to success in this role are: proven ability to work in a cross-functional environment, demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations; the ability to influence, negotiate and communicate with both internal and external customers; the ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications; and experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans.

Must be able to plan work to meet deadlines and effectively handle multiple priorities. Excellent verbal and written communication skills, including formal presentation skills are required. Written skills as evidenced by publication and journal articles are also desirable. Working knowledge of the use of Microsoft suite of software products including Excel and Word is required. Proficiency in PowerPoint is desired.

This position requires up to 10% annual travel.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

J2W:LI

Primary Location:North America-United States-New Jersey-Raritan
Organization: Janssen Research & Development, LLC. (6084)

Job: Drug & Product Safety Science

Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson & Johnson companies are equal opportunity employers.

Global Medical Safety Physician, Oncology, Director (1 of 2)-2207130222

Description

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Global Medical Safety Physician, Oncology, Director. This position is based in Raritan, NJ.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Global Medical Safety (GMS) Physician, Oncolgy, will report to and assist the GMS Therapeutic Area (TA) Head in the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. The GMS Physician will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the TA. The GMS Physician will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, Chief Safety Officer (CSO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the GMS physician will also contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Johnson & Johnson pharmaceutical products.

Principal responsibilities for the GMS Physician include: provide medical expertise to the GMS TA and provide medical oversight to non-physician GMS staff, provide end-to-end (Phase 1 through product life cycle) safety support and surveillance; chair a multidisciplinary Safety Management Teams (SMT) for assigned products whose responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)), as well as other activities related to managing the safety profile of assigned products; participate on TA Clinical Development Teams (CDTs) and Clinical Teams (CTs) as deemed necessary by the TA Safety Head; present medical safety and risk management evaluations as necessary to the CSO, the GMS Senior Leadership Team, and the Global Safety Council; provide input and review to key regulatory or clinical documents as appropriate, to ensure these key safety documents are of high medical and scientific quality; work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues; assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management; and participate on due diligence teams to evaluate Licensing & Acquisition opportunities.

Qualifications

An MD (or equivalent medical degree) is required. A Board Certification (or relevant national qualifications ex-US) in a relevant medical discipline is preferred. At least 5 years of post-residency/fellowship experience in clinical practice, academia, clinical research, or drug safety from the Pharmaceutical, Biotech or relevant industry experience is required, as is at least 2 years of post marketing safety or related industry experience, including experience preparing PSURs.

Also required and essential to success in this role are: proven ability to work in a cross-functional environment, demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations; the ability to influence, negotiate and communicate with both internal and external customers; the ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications; and experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans.

Must be able to plan work to meet deadlines and effectively handle multiple priorities. Excellent verbal and written communication skills, including formal presentation skills are required. Written skills as evidenced by publication and journal articles are also desirable. Working knowledge of the use of Microsoft suite of software products including Excel and Word is required. Proficiency in PowerPoint is desired.

This position requires up to 10% annual travel.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

J2W:LI

Primary Location:North America-United States-New Jersey-Raritan
Organization: Janssen Research & Development, LLC. (6084)

Job: Drug & Product Safety Science

Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson & Johnson companies are equal opportunity employers.

Global Medical Safety Physician, Infectious Disease, Director-0245130128

Description

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Global Medical Safety Physician, Infectious Disease, Director. This position is based in Titusville, NJ.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Global Medical Safety (GMS) Physician, Infectious Disease, will report to and assist the GMS Therapeutic Area (TA) Head in the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. The GMS Physician will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the TA. The GMS Physician will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, Chief Safety Officer (CSO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the GMS physician will also contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Johnson & Johnson pharmaceutical products.

Principal responsibilities for the GMS Physician include: provide medical expertise to the GMS TA and provide medical oversight to non-physician GMS staff, provide end-to-end (Phase 1 through product life cycle) safety support and surveillance; chair a multidisciplinary Safety Management Teams (SMT) for assigned products whose responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)), as well as other activities related to managing the safety profile of assigned products; participate on TA Clinical Development Teams (CDTs) and Clinical Teams (CTs) as deemed necessary by the TA Safety Head; present medical safety and risk management evaluations as necessary to the CSO, the GMS Senior Leadership Team, and the Global Safety Council; provide input and review to key regulatory or clinical documents as appropriate, to ensure these key safety documents are of high medical and scientific quality; work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues; assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management; and participate on due diligence teams to evaluate Licensing & Acquisition opportunities.

J2W:LI

Qualifications

An MD (or equivalent medical degree) is required. A Board Certification (or relevant national qualifications ex-US) in a relevant medical discipline is preferred. At least 5 years of post-residency/fellowship experience in clinical practice, academia, clinical research, or drug safety from the Pharmaceutical, Biotech or relevant industry experience is required, as is at least 2 years of post marketing safety or related industry experience, including experience preparing PSURs.

Also required and essential to success in this role are: proven ability to work in a cross-functional environment, demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations; the ability to influence, negotiate and communicate with both internal and external customers; the ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications; and experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans.

Must be able to plan work to meet deadlines and effectively handle multiple priorities. Excellent verbal and written communication skills, including formal presentation skills are required. Written skills as evidenced by publication and journal articles are also desirable. Working knowledge of the use of Microsoft suite of software products including Excel and Word is required. Proficiency in PowerPoint is desired.

This position requires up to 10% annual travel.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

J2W:LI

Primary Location:North America-United States-New Jersey-Titusville
Organization: Janssen Research & Development, LLC. (6084)

Job: Drug & Product Safety Science

Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson & Johnson companies are equal opportunity employers.

Global Medical Safety Physician, Established Products, Director-4778120501

Description

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Global Medical Safety Physician, Established Products, Director. This position can be based in Horsham, PA or Titusville, NJ.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The Global Medical Safety (GMS) Physician, Director, will report to and assist the Therapeutic Area (TA) Safety Head, Established Products (EP) in the safety assessment of the full portfolio of established products.

The GMS Physician will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the TA. The GMS Physician will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, Chief Safety Officer (CSO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities, Prescribers and/or Patients. In compliance with legal and regulatory requirements, the GMS physician will also contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Johnson & Johnson pharmaceutical products.

This physician will assist the existing physicians already assigned to EPs in carrying out the following: data review and analysis, ADR determination, CCDS updates, and ad hoc responses to Health Authority queries. Responsibilities also include reviewing and providing input on key regulatory or clinical documents (CSRs, protocols, PSURs etc.) as appropriate to ensure these key safety documents are of high medical and scientific quality. This physician will also provide safety support to new products transitioning into the EP franchise. Responsibilities will also include participation on process improvement work streams to bring efficiency and ensure compliance.

Qualifications

An MD (or equivalent medical degree) is required, as is Board Certification (or relevant national qualifications ex-US) in a relevant medical discipline. At least 5 years of post-residency/fellowship experience is required; either in clinical practice, academia, clinical research, or drug safety from the Pharmaceutical, Biotech or relevant industry experience is required. At least 1 year of postmarketing safety or related industry experience is also required, including experience preparing PSURs.

Knowledge of global safety regulations, principles of drug development and safety assessment of drugs both on the market and in development is preferred. Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally is preferred. Clinical trials experience is preferred.

Ability to influence, negotiate and communicate with both internal and external customers is key, as is the ability to work effectively as a member of a multidisciplinary team. Ability to plan work to meet deadlines and effectively handle multiple priorities is required. Excellent verbal and written communication skills, including formal presentation skills are required. Candidates must be fluent in written and spoken English. Written skills as evidenced by publication and journal articles are preferred. Working knowledge of the use of Microsoft suite of software products including Excel and Word is required. Proficiency in PowerPoint is required.

This position may require travel of up to 10% in support of business needs.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Titusville
Organization: Janssen Research & Development, LLC. (6084)

Job: Drug & Product Safety Science

Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

[MD&D]Safety Vigilance Leader-00000CMF

Description

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Job Title: Safety Vigilance Leader

Sector: MD&D (?????? ???)

Departmernt: Medical Affairs

Manage adverse event from products

1. Report AE to KFDA and global timely manner

2. Good collaboration with safety reviewer /Quality Asuarance/clinical research/Ware house and regulatory affairs

3. Educate internal employees for safety management

4. Manage evidences related to AE

5. Mange SOP related to reporting of AE to KFDA

Qualifications

1. ?? ???(??)

2 Experience of working with KFDA more than 1 year

3.Better, if fluent in English

4. PV, RA, Research ?? ???? ??

Primary Location:Asia Pacific-South Korea-Seoul-Yongsan-gu
Organization: Johnson & Johnson Medical Korea (Ltd.) (7225)
Job Function: Drug & Product Safety Operations

Johnson & Johnson companies are equal opportunity employers.

DIRECTOR 1 (MD), MEDICAL SAFETY-4776130328

Description

Johnson & Johnson Consumer Products Company, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director of Medical Safety, within the division of Medical Affairs, located in Fort Washington, PA or Skillman, NJ.

Johnson & Johnson Family of Consumer Companies develops and markets OTC drugs, nutritional products, baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S® Baby and BAND-AID® Brand, TYLENOL® and MOTRIN ®products, ZYRTEC® and BENADRYL® allergy medicines, NEUTROGENA®, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR®.

This position will provide safety expertise to Johnson & Johnson Family of Consumer Companies and is part of the Medical Affairs Safety team and will report to the North America Regional Safety Officer. This position supports the North America Regional Safety Officer in oversight of pharmacovigilance activities for JJFCC products and in ensuring compliance with local and global regulations and company policies. This position provides medical input to and execution of health hazard assessments, and works collaboratively with Quality Assurance, Regulatory Affairs, Consumer Medical Safety and others on the assessment of potential safety issues with regard to manufacturing quality. This position will also work in collaboration with Global Medical Safety (GMS), Regulatory Compliance, Office of Consumer Medical Safety (OCMS), and MCH business/functional units to identify, evaluate and communicate safety and/or compliance issues. Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, the responsibilities for this position include, ensure safety reporting activities are conducted in accordance with company policies, regulatory requirements and good clinical and manufacturing standards. Providing medical input to and oversight of the execution of the safety section of the McNeil Manufacturing Quality Assurance Annual Product Reviews, working collaboratively with Quality Assurance, Regulatory Affairs, Consumer Medical Safety and others on the assessment of potential safety issues with regard to manufacturing quality. Leading and performing medical safety assessments and health hazard evaluations of new and existing products. Supporting other safety related activities such as review of periodic adverse event reviews (PADERs/PSURs), clinical trial protocols, surveillance reports, and safety-related labelling changes. Collaborating with internal and external safety experts to identify process improvements, to ensure that safety reporting activities are conducted in accordance with company policies, regulatory requirements, and good clinical and manufacturing standards. Communicating/translating medical safety/technical knowledge to scientists and non-scientists. Training and mentoring other company scientists and healthcare professionals. Provide support on pharmacovigilance audits and inspections.

Qualifications

A minimum of a MD/DO degree is required. Board eligibility or certification is also required. Certification in primary care specialty (example: internal medicine, emergency medicine, family practice or pediatrics) with post- residency patient care experience is preferred. Clinical pharmacology, toxicology, epidemiology and academic experience is a plus. A minimum of 7 years experience within the pharmaceutical industry is required. 4 years experience in Safety/Pharmacovigilance is required. An understanding of regulatory requirements, product quality management and Good Manufacturing Practices is preferred. Experience with pharmacovigilance of OTC products is a plus. The ability to manage multiple competing priorities; navigation of a matrix environment; leadership as well as team member skills; strong written, oral and interpersonal skills; and sound medical judgment. Minimal travel is required between Fort Washington, PA and Skillman, NJ. This position is located in Ft. Washington, PA or Skillman, NJ.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

J2W:LI

Primary Location:North America-United States-New Jersey-Skillman
Other Locations:North America-United States-Pennsylvania-Fort Washington
Organization: Johnson & Johnson Consumer Inc. (6071)

Job: Medical Affairs

Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

EHS(Environmental, Health and Safety, Sustainability) Manager (????: ??)-00000C4J

Description

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues

Position : EHS (Environmental, Health and Safety) Manager / ?, ???

???: ?? ?? (??? ??? ????)

Job scope :

-

- Oversees the development, planning and implementation of environmental, health and safety policies and procedures within the company.
- Ensures compliance with local government regulations pertaining to environmental health and safety, and handles contract with appropriate agencies.
- Coaches and advises the environmental, health and safety staff and management on ways to improve outcomes and programs in their areas.
- Ensures appropriate corrective action is taken where environmental, health and safety hazards exist.
- Oversees the development of company training programs for employees in areas such as hazardous material handling, emergency response, industrial hygiene, electrical safety, and machine safety.
- Coordinates various councils and teams to reduce exposure to environmental, health and safety issues.
- Manages these teams to implement necessary companywide changes.
- Provides upper management with ongoing consultation pertaining to environmental, health and safety regulations identifying the impacts of changes to regulations on key business objectives.

Qualifications

Industrial safety certificate required (??????/???? ??)

Environment related certificate preferred (????(??, ??, ???) ??? ??)
Able to speak in local languages and a working knowledge of English

?? ?? 5? ?? (??? ?? ??, ??? ?? ??)

Primary Location:Asia Pacific-South Korea-Gyeonggi-do-Hwaseong-si
Organization: Janssen Korea, Ltd. (7220)
Job Function: Environmental Health & Safety

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Global Medical Safety Physician, Infectious Disease, Director Job (Titusville, NJ, US)

Global Medical Safety Physician, Established Products, Director Job (Titusville, NJ, US)

[MD&D]Safety Vigilance Leader Job (Yongsan-gu, KR)

DIRECTOR 1 (MD), MEDICAL SAFETY Job (Skillman, NJ, US)

EHS(Environmental, Health and Safety, Sustainability) Manager (공장근무: 화성) Job (Hwaseong-si, KR)