Director, Medical Safety Assessment Physician

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• Lead safety activities and benefit‑risk strategies for assigned BMS compounds/programs and chair the product Safety Management Team(s).
• Oversee, prepare and/or review aggregate safety review documents and safety sections of relevant clinical trial documents and regulatory filings.
• Lead a team in the evaluation and management of safety signals emerging from any data source; develop strategy and document outcomes.
• Lead safety labeling activities for assigned products/program; act as the Safety Subject Matter Expert for regulatory product labeling and support regional safety labeling efforts.
• Lead process improvement projects and assist the MSA Therapeutic Area Head/Lead in developing state‑of‑the‑art PV processes and procedures within BMS R&D and PS.
• Support the EU Qualified Person for Pharmacovigilance or other regional/local Qualified Person for PV regarding assigned products.
• Provide input to R&D publication strategy/plan and ensure safety input to publications and presentations.
• Actively drive safety strategy preparation and represent PS at Health Authority and Data Monitoring Committee meetings.
• Ensure all tasks are performed efficiently, with quality, accuracy and timeliness, in accordance with global regulatory requirements and BMS cost‑effectiveness goals.
• Promote collegiality and teamwork among peers; mentor and support colleagues as a positive change agent.

• Lead safety activities and benefit‑risk strategies for assigned BMS compounds and chair the product SMT(s).
• Oversee, prepare and review aggregate safety review documents, safety sections of clinical trial documents, and regulatory filings.
• Lead the team in evaluating and managing signals emerging from any data source and document findings.
• Lead safety labeling activities and support safety input for regulatory product labeling.
• Support the EU QPPV or other regional/local Qualified Person for PV on issues related to assigned products.
• Support R&D publication strategy and ensure safety input to publications and presentations.

• Act as the global safety lead for assigned compounds in development and provide safety lead support for global submission document production.
• Lead medical safety development and execution of benefit‑risk management strategies for assigned products.
• Provide safety input to clinical development plans, study protocols, amendments, and related documents.
• Lead development of safety risk language, risk management strategy, pre‑filing safety activities, and safety‑focused publication development.
• Perform medical safety review of development update safety reports, annual reports and other periodic safety submissions.
• Support safety strategy preparation for pre‑submission, Advisory Committee, Scientific Advice, DMC and other meetings.

• Act as the safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions.
• Provide medical safety and benefit‑risk input for safety aggregate reports, product renewal submissions, postmarketing study documents and responses to Health Authority queries.
• Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
• Lead safety signal evaluation and management; prepare and review reports on safety signals and ad‑hoc regulatory responses.
• Provide postmarketing safety study guidance to groups including epidemiology, medical affairs, investigator‑sponsored research, epidemiology studies and non‑interventional safety studies.
• Ensure safety labeling reflects emerging postmarketing safety profile.

• Lead process improvement projects and assist the MSA TA Head/Lead in…