Director, Medical Safety Assessment Physician
Bristol Myers Squibb
6 days ago
Remote friendly (Lawrence, 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/review aggregate safety review documents and safety sections of clinical trial documents and regulatory filings.
- Lead evaluation/management of safety signals; develop signal evaluation strategy and document outcomes.
- Lead safety labeling activities; serve as Safety Subject Matter Expert for regulatory labeling; support cross-functional labeling meetings and regional labeling.
- Lead process improvement projects; develop/maintain PV processes/procedures.
- Support EU Qualified Person for Pharmacovigilance (or other regional/local QP) for assigned products.
- Provide safety input to R&D publication strategy/plan and publications/presentations.
- Drive safety strategy preparation; represent PS at Health Authority and DMC meetings.
Responsibilities (key)
- Act as global safety lead in development; provide safety input for submission document production and clinical development documents.
- Lead medical safety development/execution of benefit-risk management and safety risk language/Risk Management strategy.
- Act as safety lead for marketed products; oversee postmarketing safety activities, risk management/RMP elements, and safety signal reports.
- Support regulatory inspections, issue/crisis management, patient safety team collaboration, and hiring/orientation.
- Provide cross-functional input/training on safety profiles; serve as PS liaison.
Qualifications
- MD/equivalent required; postgraduate psychiatry or neurology preferred.
- 3+ years in PV or relevant pharma/biomedical field strongly preferred.
Skills/Abilities
- PV and drug development life-cycle safety evaluation; observational research tools.
- Regulatory safety assessment/action knowledge; strong analytical reasoning.
- Manage multiple projects; attention to detail; work/lead in matrix; excellent verbal/written communication.
Benefits (explicit)
- Health coverage; wellbeing support; 401(k), disability/life insurance, and other financial protections.
- Paid time off (flexible time off or annual vacation depending on location/employee type).
- Lead safety activities and benefit-risk strategies for assigned compounds/program; chair product Safety Management Team(s).
- Oversee/review aggregate safety review documents and safety sections of clinical trial documents and regulatory filings.
- Lead evaluation/management of safety signals; develop signal evaluation strategy and document outcomes.
- Lead safety labeling activities; serve as Safety Subject Matter Expert for regulatory labeling; support cross-functional labeling meetings and regional labeling.
- Lead process improvement projects; develop/maintain PV processes/procedures.
- Support EU Qualified Person for Pharmacovigilance (or other regional/local QP) for assigned products.
- Provide safety input to R&D publication strategy/plan and publications/presentations.
- Drive safety strategy preparation; represent PS at Health Authority and DMC meetings.
Responsibilities (key)
- Act as global safety lead in development; provide safety input for submission document production and clinical development documents.
- Lead medical safety development/execution of benefit-risk management and safety risk language/Risk Management strategy.
- Act as safety lead for marketed products; oversee postmarketing safety activities, risk management/RMP elements, and safety signal reports.
- Support regulatory inspections, issue/crisis management, patient safety team collaboration, and hiring/orientation.
- Provide cross-functional input/training on safety profiles; serve as PS liaison.
Qualifications
- MD/equivalent required; postgraduate psychiatry or neurology preferred.
- 3+ years in PV or relevant pharma/biomedical field strongly preferred.
Skills/Abilities
- PV and drug development life-cycle safety evaluation; observational research tools.
- Regulatory safety assessment/action knowledge; strong analytical reasoning.
- Manage multiple projects; attention to detail; work/lead in matrix; excellent verbal/written communication.
Benefits (explicit)
- Health coverage; wellbeing support; 401(k), disability/life insurance, and other financial protections.
- Paid time off (flexible time off or annual vacation depending on location/employee type).