Director, Medical Safety Assessment Physician, Neuro - Cambridge C. MA

Eligibility

Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers.

On‑Site location: as detailed in the job post.

Lead safety activities and benefit‑risk strategies for assigned BMS compounds/programs and chair the product Safety Management Team(s).

• Oversee, prepare, and review aggregate safety review documents and safety sections of relevant clinical trial documents and regulatory filings.
• Lead the team in the evaluation and management of safety signals emerging from any data source; develop strategy for signal evaluation and document outcomes.
• Lead safety labeling activities for assigned products/program; act as the Safety Subject Matter Expert for regulatory product labeling and provide input at cross‑functional labeling meetings.
• Lead process improvement projects and assist the MSA Therapeutic Area Head/Lead in maintaining state‑of‑the‑art pharmacovigilance processes within BMS R&D and PS.
• Support the EU Qualified Person for Pharmacovigilance or other regional/local Qualified Person for PV on issues relating to assigned products.
• Provide input to the R&D publication strategy/plan and ensure safety input to publications and presentations.
• Drive safety strategy preparation and represent PS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.
• Ensure tasks are performed efficiently, accurately, and timely 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.
• Act as the global safety lead for assigned compounds in development, supporting global submission document production and review of draft summary documents.
• Lead medical safety development and execution of benefit‑risk management strategies for assigned products.
• Provide safety input to clinical development plans, study protocols, amendments, investigator brochures, statistical analysis plans, informed consent forms, clinical study reports, and responses to HA or IRB/EC queries.
• Lead development of safety risk language, risk‑management strategy, and pre‑filing safety activities (including safety table shells, integrated safety data review, and safety summarizations).
• Perform medical safety review of development update safety reports, annual reports, and other periodic safety submissions.
• Support safety strategy preparation for pre‑submission meetings, Advisory Committee meetings, Scientific Advice meetings, and DMC meetings.
• Act as the safety lead for assigned marketed compounds, supporting global post‑marketing safety activities and submissions.
• Provide medical safety and benefit‑risk input for safety aggregate reports, product renewal submissions, post‑marketing study documents, and responses to HA queries.
• Lead medical safety oversight 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 post‑marketing safety study guidance to investigator‑sponsored research, epidemiology studies, and non‑interventional safety studies.
• Ensure safety labeling reflects the emerging post‑marketing safety profile.
• Assist the team and senior management in issue management and crisis management.
• Liaise with all TA staff to maintain an effective and collaborative patient safety team.
• Support hiring and orientation of new team members.
• Provide input to strategic plans for safety differentiation of BMS products.
• Prepare and provide training to BMS employees on product safety profiles and issues.
• Act as PS liaison for assigned products with BMS functions (Legal, BD, Operations, Marketing, etc.).
• Support manufacturing quality and co‑author integrated health hazard assessments.
• Develop communications of safety data and interpretation to BMS and external parties worldwide.

• MD or equivalent required; postgraduate qualification or experience in psychiatry or neurology is preferred.
• 3+ years in pharmacovigilance or a relevant pharmaceutical/biomedical field (e.g., Medical, Clinical, Regulatory) strongly preferred.
• Understanding of the drug development process and pharmacovigilance principles.
• Knowledge of safety assessment and regulatory requirements across the life cycle of a drug product.
• Proficient in leveraging tools to investigate safety concerns, including observational research.
• Strong scientific analytical reasoning skills.
• Ability to work on multiple projects in parallel and attention to detail.
• Behavioral competencies to lead within a complex matrix environment.
• Excellent verbal and written communication skills.

Cambridge Crossing: $286,560 - $347,244

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Princeton – NJ – US: $255,860 - $310,040

Cambridge Crossing, Massachusetts, United States