Director, Medical Pharmacovigilance - (Job Number: 0809423)

Director, Medical Pharmacovigilance - (Job Number: 0809423) DescriptionCentocor Inc., a member of Johnson && Johnson's Family of Companies, is recruiting for a Director (Pharmacovigilance), located in Raritan, NJ. Centocor Research and Development, develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. The Director, Medical Pharmacovigilance will report to and assist the Senior Director, Medical Pharmacovigilance in the safety assessment of Johnson && Johnson Pharmaceutical Research && Development (J&&J PRD) Oncology drugs that are either marketed or in clinical development. Key Responsibilities: Conduct appropriate data review/analysis and prepare assessments on safety issues arising from J&&J PRD-sponsored clinical trials, the J&&J postmarketing adverse event database (SCEPTRE), and/or Health Authorities. Monitor safety databases for significant safety issues of J&&JPRD Oncology products in conjunction with the J&&J Benefit Risk Management department and PRD business partners as appropriate. Provide support to product development and research programs in CR&&D and Medical Affairs with respect to safety and risk management issues for J&&JPRD Oncology products that are marketed or in development. Participate on review team and/or author key safety sections of Risk Management Plans, Investigator Brochures, Regulatory responses, etc. Participate as a member of Safety Review Team. Lead Interdisciplinary Safety Review (ISR) meetings with clinical development for J&&JPRD Oncology products that are marketed or in development. Collaborate with Clinical Product Teams, Benefit Risk Management Department, Regulatory Affairs, Medical Affairs and PRD Business Partners to provide safety support of J&&JPRD Oncology products that are marketed or in development. Other responsibilities: This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. A minimum of a Board Certified/Board Eligible MD is required. Preferred areas of training include Oncology, Internal Medicine, Pediatrics, Family Practice, although not required. Candidate must possess 3 or more years pharmaceutical/CRO/biotech industry experience in pharmacovigilance. Experience with the assessment of drug risks and benefits for both marketed drugs and drugs in development as well as a good understanding of drug development and global safety regulations are required. Excellent written and verbal communication skills are required. Must be proficient in Microsoft Word. Proficiency in Microsoft Excel and Powerpoint is preferred. 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