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Fort Washington, PA, US

Product Vigilance Physician (Consumer), Office of Medical Safety-7183121010

Description

Johnson & Johnson Consumer Products Company, a member of the Johnson & Johnson family of companies, is recruiting for a Product Vigilance Physician (Consumer) for its location in Fort Washington, Pa.

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.

The Associate Director, Product Vigilance Physician (ADPVP) is the medical expert overseeing the evaluation and determination of seriousness, causality, and reportability of adverse events and product problem reports for the monograph drugs, medical devices, and cosmetic products of the Johnson & Johnson Group of Consumer Companies that are managed in the Remetrex Safety System (RSS).

The ADPVP primary responsibility is monitoring PVP operations including staff, contractors, and consultants and PVP -related processes, including day to day management, process development, quality control, and continuous improvement.

Additionally, the ADPVP will ensure timely medical decisions and documentation related to case reportability to health authorities worldwide.

Additional responsibilities include: conduct the medical evaluation and determination of seriousness and causality of adverse event and product quality complaint reports, including but not limited to, all serious, expedited and pregnancy reports; medical device malfunctions/quality complaints associated with adverse events, and review of (non-serious) line listings; provide medical guidance to drug safety associates and other scientific staff in the initial evaluation and follow-up of individual case safety reports, including seriousness, causality and reportability decisions; conduct ad-hoc safety/regulatory reporting projects and provide medical input and opinion for ad-hoc queries and safety assessments as requested; responsible for all safety aspects pertaining to assigned products, including medical guideline updates; participate in surveillance and signal detection efforts, e.g. GSRG, CVRB, strategy meetings and other medical/scientific meetings; and participate as core member of the inspection readiness team responsible for regulatory compliance and inspection preparation.

This position requires up to 10% global and domestic travel in support of business needs.

Qualifications


An MD or equivalent is required for this position. Medical specialization in pediatrics, internal medicine, general/family practice, or dermatology is preferred. A minimum of 3 years of experience in marketed product safety and/or clinical experience is also required.

Expert level knowledge and hands-on experience in medical case review and product vigilance is highly preferred, as is an advanced level understanding of US and international pharmacovigilance, medical device and cosmetic safety regulations. People management experience is preferred.

This position requires up to 10% global and domestic travel 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-Pennsylvania-Fort Washington
Organization: Johnson & Johnson Consumer Inc. (6071)