Director, Medical Safety Assessment Physician, Neuroscience
Bristol Myers Squibb
July 01, 2026
Remote friendly (Princeton, NJ)
United States
Medical Affairs
Position Summary
- Lead safety activities and benefit-risk strategies for assigned compounds/program; chair product Safety Management Team(s).
- Oversee, prepare, and/or review aggregate safety review documents and safety sections of clinical trial documents and regulatory filings.
- Lead evaluation and management of safety signals; develop signal evaluation strategy and document outcomes.
- Lead safety labeling activities; act as Safety Subject Matter Expert for regulatory product labeling; provide regional labeling support.
- Lead PV process improvement projects; support state-of-the-art pharmacovigilance (PV) processes and procedures.
- Support EU Qualified Person for PV (or other regional/local Qualified Person).
- Provide safety input to R&D publications/presentations.
- Drive safety strategy preparation and represent PS at Health Authority and DMC meetings.
Duties/Responsibilities
- Global safety lead for compounds in development; lead benefit-risk management and safety risk language/risk management strategy.
- Provide safety input to clinical development documents (plans, protocols, amendments, IB, SAP, ICF, CSR, HA/IRB/EC queries).
- Perform medical safety review of periodic safety reports and submissions.
- Lead postmarketing safety activities: aggregate reports, renewal submissions, RMP execution, safety labeling updates, signal reports, and HA responses.
- Support regulatory inspection readiness, issue/crisis management, patient safety team collaboration, and hiring/orientation.
Qualifications
- MD/equivalent required; postgraduate psychiatry or neurology preferred.
- 3+ years in PV or relevant pharmaceutical/biomedical field strongly preferred.
Required/Preferred Skills
- Drug development process understanding; PV expertise to assess safety and minimize patient risk.
- Knowledge of regulatory safety requirements; strong scientific analytical reasoning; manage multiple parallel projects; excellent attention to detail; strong written/verbal communication.
Benefits (explicitly listed)
- Health coverage; wellbeing support programs; 401(k) and disability/life/insurance benefits; paid time off.
- Lead safety activities and benefit-risk strategies for assigned compounds/program; chair product Safety Management Team(s).
- Oversee, prepare, and/or review aggregate safety review documents and safety sections of clinical trial documents and regulatory filings.
- Lead evaluation and management of safety signals; develop signal evaluation strategy and document outcomes.
- Lead safety labeling activities; act as Safety Subject Matter Expert for regulatory product labeling; provide regional labeling support.
- Lead PV process improvement projects; support state-of-the-art pharmacovigilance (PV) processes and procedures.
- Support EU Qualified Person for PV (or other regional/local Qualified Person).
- Provide safety input to R&D publications/presentations.
- Drive safety strategy preparation and represent PS at Health Authority and DMC meetings.
Duties/Responsibilities
- Global safety lead for compounds in development; lead benefit-risk management and safety risk language/risk management strategy.
- Provide safety input to clinical development documents (plans, protocols, amendments, IB, SAP, ICF, CSR, HA/IRB/EC queries).
- Perform medical safety review of periodic safety reports and submissions.
- Lead postmarketing safety activities: aggregate reports, renewal submissions, RMP execution, safety labeling updates, signal reports, and HA responses.
- Support regulatory inspection readiness, issue/crisis management, patient safety team collaboration, and hiring/orientation.
Qualifications
- MD/equivalent required; postgraduate psychiatry or neurology preferred.
- 3+ years in PV or relevant pharmaceutical/biomedical field strongly preferred.
Required/Preferred Skills
- Drug development process understanding; PV expertise to assess safety and minimize patient risk.
- Knowledge of regulatory safety requirements; strong scientific analytical reasoning; manage multiple parallel projects; excellent attention to detail; strong written/verbal communication.
Benefits (explicitly listed)
- Health coverage; wellbeing support programs; 401(k) and disability/life/insurance benefits; paid time off.