Director, Leader Medical Pharmacovigilance, PRD Oncology - (Job Number: 0715909)

Director, Leader Medical Pharmacovigilance, PRD Oncology - (Job Number: 0715909) DescriptionJohnson & Johnson Pharmaceutical Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Leader Medical Pharmacovigilance PRD Oncology, located in Raritan, NJ. Johnson & Johnson Pharmaceutical 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 Director, Medical Pharmacovigilance Physician will report to and assist the Vice President, Pharmacovigilance, Clinical Quality and Compliance in the safety assessment of Johnson and Johnson Pharmaceutical Research & Development (J&JPRD) Oncology drugs that are either marketed or in clinical development. Key Responsibilities: Supervise J&JPRD Oncology Pharmacovigilance department in Raritan. This supervisory role will ensure alignment, quality and efficiency in adverse event signal detection for marketed products and products in development, Pharmacovigilance SOP training and implementation, audit preparation and response, oral and written communication with Health Authorities, and additions/revisions to safety information contained in the Company Core Data Sheet and local labels. Monitor the safety databases of J&JPRD Oncology marketed products and products in development for significant safety issues in conjunction with J&J Benefit Risk Management. Provide medical expertise to the Pharmacovigilance department. Assist in ensuring that pertinent safety findings associated with Oncology products are reported in an appropriate and timely manner to worldwide regulatory agencies. Assist in providing support to product development and research programs in CR&D, Medical Affairs, and Sales and Marketing with respect to medical safety and risk management issues for Oncology drugs in development and for marketed drugs. Work with the J&J Benefit Risk Management on the medical assessment of safety issues that relate to both postmarketing and clinical trial information. Participate on review team and/or author key safety sections of NDAs/BLAs, Risk Management Plans, Investigator Brochures, etc. Participate as a member of Safety Review Team. Lead and/or participate in Interdisciplinary Safety Review (ISR) meetings with clinical development for marketed Oncology products and products in development. A minimum of an MD/DO or equivalent degree is required (Internal Medicine training desired with experience in a relevant medical subspecialty). Must have a minimum of 5 or more years of pharmaceutical industry experience in drug safety, including experience with safety assessments of marketed drugs and drugs in development and risk/benefit analyses. Experience/knowledge of clinical research and analysis of clinical trial data is required. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now