Johnson & Johnson companies are equal opportunity employers.
DIRECTOR, PRODUCT VIGILANCE PHYSICIAN-9754131015
Description
Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc., is recruiting for a Director Product Vigilance Physician, Director (PVP), in Horsham, PA or Skillman, NJ.
Johnson & Johnson Consumer Products Company, a 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 Visine® and BAND-AID® Brand, as well as leading skin care brands such as Cortaid®, KY® and Listerine Brand®.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Reporting to the Director, Product Vigilance Physicians in the Office of Consumer Medical Safety (OCMS) of the Johnson & Johnson Family of Consumer Companies (JJFCC), the Senior Product Vigilance Physician (PVP) is a senior medical expert responsible for the medical evaluation, determination of seriousness, causality and malfunction reportability, and timely regulatory reporting of adverse event reports for the medical devices, OTCs, and cosmetics of the Johnson & Johnson Group of Consumer Companies.
The PVP will conduct hands-on, as well as direct Product Vigilance Physicians (PVP) in adverse event and device malfunction assessments; and, as required lead the medical aspects of staff training and compliance, audits and inspections, and monitoring performance indicators to achieve operational excellence. The PVP will manage medical aspects of case management processes for adverse event and medical device malfunctions; and, support the regulatory reporting in accordance with US and international regulations, standard operating procedures, and applicable contractual terms. The SPVP ensures timely medical decisions and appropriate documentation related to case reportability to the US FDA and health authorities worldwide, and shares accountability for on-time case reporting.
The PVP is a subject matter expert who provides strategic insight and guidance to the organization on medical review and reporting of adverse events/malfunctions reports to health authorities. The PVP provides guidance on the clinical severity, expectedness, causality, and correct classification of seriousness within the context of the safety profiles of company and similar products and the associated documentation and coding of adverse events. In performing these activities, the SPVP is responsible for following international product vigilance regulations, company and departmental procedures, and functional working practices. On a day-to-day basis, the PVP will assist with oversight of PVP staff, contractors and consultants; and of PVP-related processes, process development, quality control, continuous improvement; and, management communications; (b) provide medical guidance to drug safety associates, product vigilance physicians, and other scientific staff in the evaluation and follow-up of individual case safety reports, seriousness and reportability decisions for medical devices; (c) conduct the medical evaluation of adverse event and product quality complaint reports, including but not limited to all serious, expedited and pregnancy reports; medical device malfunctions associated with adverse events, and review of (non-serious) line listings; and, (d) participate in reportability determination, signal detection, safety management, complaint vigilance meetings and other medical/scientific meetings.
The PVP will work closely with Director, Medical device, Drug, and Cosmetic (MDC) operations and the Associate Director, Device Malfunction Organization(DMO) operations, making decisions about the appropriate course of action to resolve medical and malfunction review issues; escalate safety observations and alerts when necessary; and, develop close working relationships in a highly matrixed, global organization. Significant interfaces include but are not limited to MDC peers and OCMS colleagues, Regulatory Affairs and Quality Assurance. Interactions with safety, medical and regulatory staff of Operating Companies are expected to occur regularly.
Qualifications
A minimum of an MD or equivalent and a sound knowledge of general medicine is required. A minimum of 3 years of prior experience as a medical expert in marketed safety operations is required. A minimum of seven (7) years of combined experience in medical practice after residency, and, marketed product safety operations is required. An advanced level understanding of US and international medical device and related complaint vigilance regulations is preferred. Excellent written and verbal communication skills in English are required. An unrestricted medical license in the US is preferred. Demonstrated success in people management in a global, matrixed and team-oriented environment is preferred. Demonstrated medical decision-making and problem solving skills; and, a quality orientation / attention to detail / eye for accuracy is required. Expert level knowledge and hands-on experience in safety case management for regulatory reporting; and, an in-depth understanding of related product vigilance systems is preferred. Experience in product safety operations for Consumer products, monograph drugs, medical devices, or cosmetics are preferred. Experience with Health Authority Inspections is preferred. This position will be based in Horsham, PA or Skillman, NJ. This position will require up to 10% domestic and international 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-Pennsylvania-Horsham
Other Locations:North America-United States-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)
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.
DIRECTOR, PRODUCT VIGILANCE PHYSICIAN-9754131015
Description
Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc., is recruiting for a Director Product Vigilance Physician, Director (PVP), in Horsham, PA or Skillman, NJ.
Johnson & Johnson Consumer Products Company, a 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 Visine® and BAND-AID® Brand, as well as leading skin care brands such as Cortaid®, KY® and Listerine Brand®.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Reporting to the Director, Product Vigilance Physicians in the Office of Consumer Medical Safety (OCMS) of the Johnson & Johnson Family of Consumer Companies (JJFCC), the Senior Product Vigilance Physician (PVP) is a senior medical expert responsible for the medical evaluation, determination of seriousness, causality and malfunction reportability, and timely regulatory reporting of adverse event reports for the medical devices, OTCs, and cosmetics of the Johnson & Johnson Group of Consumer Companies.
The PVP will conduct hands-on, as well as direct Product Vigilance Physicians (PVP) in adverse event and device malfunction assessments; and, as required lead the medical aspects of staff training and compliance, audits and inspections, and monitoring performance indicators to achieve operational excellence. The PVP will manage medical aspects of case management processes for adverse event and medical device malfunctions; and, support the regulatory reporting in accordance with US and international regulations, standard operating procedures, and applicable contractual terms. The SPVP ensures timely medical decisions and appropriate documentation related to case reportability to the US FDA and health authorities worldwide, and shares accountability for on-time case reporting.
The PVP is a subject matter expert who provides strategic insight and guidance to the organization on medical review and reporting of adverse events/malfunctions reports to health authorities. The PVP provides guidance on the clinical severity, expectedness, causality, and correct classification of seriousness within the context of the safety profiles of company and similar products and the associated documentation and coding of adverse events. In performing these activities, the SPVP is responsible for following international product vigilance regulations, company and departmental procedures, and functional working practices. On a day-to-day basis, the PVP will assist with oversight of PVP staff, contractors and consultants; and of PVP-related processes, process development, quality control, continuous improvement; and, management communications; (b) provide medical guidance to drug safety associates, product vigilance physicians, and other scientific staff in the evaluation and follow-up of individual case safety reports, seriousness and reportability decisions for medical devices; (c) conduct the medical evaluation of adverse event and product quality complaint reports, including but not limited to all serious, expedited and pregnancy reports; medical device malfunctions associated with adverse events, and review of (non-serious) line listings; and, (d) participate in reportability determination, signal detection, safety management, complaint vigilance meetings and other medical/scientific meetings.
The PVP will work closely with Director, Medical device, Drug, and Cosmetic (MDC) operations and the Associate Director, Device Malfunction Organization(DMO) operations, making decisions about the appropriate course of action to resolve medical and malfunction review issues; escalate safety observations and alerts when necessary; and, develop close working relationships in a highly matrixed, global organization. Significant interfaces include but are not limited to MDC peers and OCMS colleagues, Regulatory Affairs and Quality Assurance. Interactions with safety, medical and regulatory staff of Operating Companies are expected to occur regularly.
Qualifications
A minimum of an MD or equivalent and a sound knowledge of general medicine is required. A minimum of 3 years of prior experience as a medical expert in marketed safety operations is required. A minimum of seven (7) years of combined experience in medical practice after residency, and, marketed product safety operations is required. An advanced level understanding of US and international medical device and related complaint vigilance regulations is preferred. Excellent written and verbal communication skills in English are required. An unrestricted medical license in the US is preferred. Demonstrated success in people management in a global, matrixed and team-oriented environment is preferred. Demonstrated medical decision-making and problem solving skills; and, a quality orientation / attention to detail / eye for accuracy is required. Expert level knowledge and hands-on experience in safety case management for regulatory reporting; and, an in-depth understanding of related product vigilance systems is preferred. Experience in product safety operations for Consumer products, monograph drugs, medical devices, or cosmetics are preferred. Experience with Health Authority Inspections is preferred. This position will be based in Horsham, PA or Skillman, NJ. This position will require up to 10% domestic and international 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-Pennsylvania-Horsham
Other Locations:North America-United States-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)
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.