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Director, Medical Safety Assessment Physician
2 months ago
Bristol-Myers Squibb Company is seeking a highly skilled Director, Medical Safety Assessment Physician to join our team. As a key member of our Worldwide Patient Safety group, you will be responsible for ensuring the safety of our medicines and leading safety activities and benefit-risk strategies for assigned BMS compounds/programs.
Key Responsibilities- Lead safety activities and benefit-risk strategies for assigned BMS compounds/programs in the Immunology Therapeutic Area (TA) and chair the product Safety Management Team(s).
- Oversee, prepare, and/or review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
- Lead team in the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation and document outcome.
- Lead safety labeling activities for assigned products/program. Act as the Safety Subject Matter Expert for input to regulatory product labeling.
- Lead process improvement projects. Assist the Medical Safety Assessment (MSA) TA Head/Lead in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures within BMS Drug Development and WWPS.
- MD/equivalent required. Postgraduate qualification or experience in internal medicine, immunology, or related specialty desirable.
- 3+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred.
- Strong scientific analytical reasoning skills. Ability to work on multiple projects in parallel. Excellent attention to detail.
Bristol-Myers Squibb Company is a leading biopharmaceutical company dedicated to transforming patients' lives through science. Our unique culture promotes diversity, inclusion, and innovation, and we are committed to making a positive impact on the communities we serve.
