Medical Safety Assessment Physician
4 weeks ago
As a Medical Safety Assessment Physician at Bristol-Myers Squibb Company, you will play a critical role in ensuring the safety of our medicines. You will 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).
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. Participate/provide input at cross-functional labeling team meetings and provide regional safety labeling support.
- 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.
- Support the EU Qualified Person for PV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
- Provide input to Drug Development publication strategy/plan & ensure safety input to publications/presentations.
- Actively drive safety strategy preparation and represent WWPS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.
- 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.
- Knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
- Proficient ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
- Understanding of regulatory requirements for safety assessment and action.
- Strong scientific analytical reasoning skills.
- Ability to work on multiple projects in parallel.
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