Pharmaceuticals Medical Safety Officer - Director-00000OCS
Description
Position Summary:
The Pharmaceuticals Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Medical Safety organization and has accountability for assessing the Medical Safety of products or product families and the reasonable mitigation of risk associated with such products.
The MSO will report to and assist the Global Medical Safety Therapeutic Area (TA) Safety Head in the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. The MSO 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 MSO will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, Head of Medical Safety Assessment (MSA), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the MSO will also contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen Research & Development, LLC products.
Principal responsibilities:
- Provide medical expertise to the GMS TA and provide medical oversight to non-physician GMS staff including
- Defining the safety question or issue requiring medical safety assessment
- Developing the strategy for the safety review and analysis
- Interpreting results and determining the medical importance of question or issue
- Reviewing and approving (i.e., signatory) for medical assessment reports, e.g. ad hoc safety reports
- 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 CMO, the GMS Senior Leadership Team, and the Pharmaceuticals Medical Safety Council (MSC)
- Participate in HA interactions regarding safety and risk management, both written and verbal
- 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. These might include:
- Clinical Trial Protocols
- Safety Sections of Investigator’s Brochure (IB) and IB addenda
- Clinical Study Reports (CSR)
- Annual Safety Reports (ASR)
- Integrated Safety Summary (ISS) and Summary of Clinical Safet (SCS)for NDA/BLA/MAA filings
- Periodic Safety Update Report (PSUR)
- Core Data Sheets (CDS)
- Informed Consent Form Risk Template
- 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
- Participate on due diligence teams to evaluate Licensing & Acquisition opportunities
Working Relationships/interfaces:
Global Medical Safety is a functional area within the Global Medical Organization
Contacts Inside the Company:
- All Clinical Therapeutic Areas
- CMO, Pharma
- QPPV Pharma
- Medical Safety Officers and Scientists in Medical Safety Assessment, including GMS Risk Management
- Other groups within GMS including Pharmacovigilance Analytics and Insight (PVAI), Pharmacovigilance Operations (PVO), and Compliance Standards and Alliances (CSA)
- Epidemiology
- Strategic Product Development
- Business Development
- Global Regulatory Affairs and Global Labeling
- Global / Regional Medical Affairs
- CDOs, including Biostatistics and Regulatory Medical Writing
Contacts Outside the Company:
- Clinical and Epidemiology Consultants and Advisors
- Regulatory Agencies
- Development Partners and Potential Partners
- Business Partners
- CROs
Qualifications
Education and Experience:
- Physician (MD or equivalent), generally requires 8-10 years related experience with Board Certification (if US) preferred
- Demonstrated skills in clinical medicine and/or Pharmacovigilance highly preferred
- 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
- Ability to influence, negotiate and communicate with both internal and external customers
Required Technical Knowledge and Skills:
- 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.
- 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
- Able to plan work to meet deadlines and effectively handle multiple priorities
- Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable
- Fluent in written and spoken English
- Working knowledge of the use of Microsoft suite of software products including Excel and Word.
- Proficiency in PowerPoint is desired
What’s in it for you …?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Other Locations:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Pharmacovigilance
Description
Position Summary:
The Pharmaceuticals Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Medical Safety organization and has accountability for assessing the Medical Safety of products or product families and the reasonable mitigation of risk associated with such products.
The MSO will report to and assist the Global Medical Safety Therapeutic Area (TA) Safety Head in the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. The MSO 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 MSO will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, Head of Medical Safety Assessment (MSA), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the MSO will also contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen Research & Development, LLC products.
Principal responsibilities:
- Provide medical expertise to the GMS TA and provide medical oversight to non-physician GMS staff including
- Defining the safety question or issue requiring medical safety assessment
- Developing the strategy for the safety review and analysis
- Interpreting results and determining the medical importance of question or issue
- Reviewing and approving (i.e., signatory) for medical assessment reports, e.g. ad hoc safety reports
- 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 CMO, the GMS Senior Leadership Team, and the Pharmaceuticals Medical Safety Council (MSC)
- Participate in HA interactions regarding safety and risk management, both written and verbal
- 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. These might include:
- Clinical Trial Protocols
- Safety Sections of Investigator’s Brochure (IB) and IB addenda
- Clinical Study Reports (CSR)
- Annual Safety Reports (ASR)
- Integrated Safety Summary (ISS) and Summary of Clinical Safet (SCS)for NDA/BLA/MAA filings
- Periodic Safety Update Report (PSUR)
- Core Data Sheets (CDS)
- Informed Consent Form Risk Template
- 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
- Participate on due diligence teams to evaluate Licensing & Acquisition opportunities
Working Relationships/interfaces:
Global Medical Safety is a functional area within the Global Medical Organization
Contacts Inside the Company:
- All Clinical Therapeutic Areas
- CMO, Pharma
- QPPV Pharma
- Medical Safety Officers and Scientists in Medical Safety Assessment, including GMS Risk Management
- Other groups within GMS including Pharmacovigilance Analytics and Insight (PVAI), Pharmacovigilance Operations (PVO), and Compliance Standards and Alliances (CSA)
- Epidemiology
- Strategic Product Development
- Business Development
- Global Regulatory Affairs and Global Labeling
- Global / Regional Medical Affairs
- CDOs, including Biostatistics and Regulatory Medical Writing
Contacts Outside the Company:
- Clinical and Epidemiology Consultants and Advisors
- Regulatory Agencies
- Development Partners and Potential Partners
- Business Partners
- CROs
Qualifications
Education and Experience:
- Physician (MD or equivalent), generally requires 8-10 years related experience with Board Certification (if US) preferred
- Demonstrated skills in clinical medicine and/or Pharmacovigilance highly preferred
- 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
- Ability to influence, negotiate and communicate with both internal and external customers
Required Technical Knowledge and Skills:
- 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.
- 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
- Able to plan work to meet deadlines and effectively handle multiple priorities
- Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable
- Fluent in written and spoken English
- Working knowledge of the use of Microsoft suite of software products including Excel and Word.
- Proficiency in PowerPoint is desired
What’s in it for you …?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Other Locations:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Pharmacovigilance