Manager, Medical Pharmacovigilance - (Job Number: 0809528)

Manager, Medical Pharmacovigilance - (Job Number: 0809528) DescriptionCentocor Inc., a member of Johnson && Johnson's Family of Companies, is recruiting for a Manager, Medical 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. This position will report to the Senior Director of Medical Pharmacovigilance and assist in supporting the safety assessment of Johnson && Johnson Pharmaceutical Research && Development (J&&JPRD) Oncology drugs that are either marketed or in clinical development. Key responsibilities: Assist in the retrieval, compilation and assessment of safety data from multiple data sources including J&&JPRD sponsored clinical trials, postmarketing adverse event database (SCEPTRE), and/or Health Authorities to respond to ad hoc queries on J&&JPRD Oncology products that are marketed or in clinical development. Assist in the preparation including authoring sections of safety reports/documents such as ad hoc safety reports and Risk Management Plans. Provide project management support to Medical Pharmacovigilance Directors e.g., defining deliverables, timelines and tracking to help ensure on-time completion of safety and risk management projects involving J&&JPRD Oncology products that are marketed or in development. Coordinate and assist in the data preparation/analysis for Interdisciplinary Safety Review meetings. Participate in meetings and working groups that support 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 reponsibilities: This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. A minimum of a Bachelor's Degree in Nursing, Pharmacy or other clinically-oriented biomedical science is required. A minimum of 5 years of pharmaceutical/CRO/biotech industry experience is required including a minimum of 3 years drug safety experience in clinical trials, spontaneous reports and safety evaluation. Proficiency in Microsoft Word is required. Proficiency in Excel and PowerPoint are highly desired. Must have excellent written and verbal communication skills. Must be organized and detail-oriented. Must be able to work independently in a fast paced environment and effectively handle mutiple priorities. 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