Director, Patient Safety Scientist
Bristol Myers Squibb
4 days ago
Remote friendly (Madison, NJ)
United States
Medical Affairs
Position Summary
Director, Patient Safety Scientist partners with the MSAP/SMT Chair to characterize conditions for safe use of BMS medicines by evaluating and mitigating risks; independently leads signal detection and safety data review meetings (SDRMs); ensures pharmacovigilance regulatory compliance.
Responsibilities
- Develop/co-develop global safety strategy across the product lifecycle for multiple complex compounds; lead signal evaluation (case series, literature, health authority/claims databases), producing signal reports and conclusions with tracking and documentation.
- Provide medical writing for safety/risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER).
- Lead ad hoc health authority responses; support safety labeling updates reflecting emerging postmarketing profiles.
- Prepare/review safety sections for clinical trial documents (protocols, CSRs, IBs/RSI, ICFs, contraception language) and represent Patient Safety at internal/external meetings.
- Co-develop safety strategy and author safety sections for regulatory filings/MAAs (e.g., safety table shells, ISS, SCS, clinical overview, briefing docs, initial labeling: USPI/CCDS/SmPC); lead responses to ad hoc regulatory safety requests.
- Create/update EDSR; provide leadership/accountability for global/EU Risk Management Plans (RMPs); oversee additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally.
- Oversee a global safety/risk management team; drive digital/AI-enabled efficiency; support inspections/audits.
Degree & Experience Requirements
- Scientific degree (BS/MS/RN/PharmD/PhD/MD) or equivalent education + relevant experience.
- Minimum 8 years relevant pharmacovigilance/pharma industry/drug development experience; demonstrated ability to mentor/coach.
Key Competencies
- Safety strategy execution; strong scientific/medical synthesis of complex data; sound judgment; matrix leadership; adaptability; use of AI/automation/digital tools with scientific rigor.
Compensation/Benefits (as stated)
- Madison–Giralda–NJ (US): $217,520–$263,577 base range; additional incentive opportunities may be available.
Application Instructions
- If the role doesn’t fully match your resume, apply anyway.
Director, Patient Safety Scientist partners with the MSAP/SMT Chair to characterize conditions for safe use of BMS medicines by evaluating and mitigating risks; independently leads signal detection and safety data review meetings (SDRMs); ensures pharmacovigilance regulatory compliance.
Responsibilities
- Develop/co-develop global safety strategy across the product lifecycle for multiple complex compounds; lead signal evaluation (case series, literature, health authority/claims databases), producing signal reports and conclusions with tracking and documentation.
- Provide medical writing for safety/risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER).
- Lead ad hoc health authority responses; support safety labeling updates reflecting emerging postmarketing profiles.
- Prepare/review safety sections for clinical trial documents (protocols, CSRs, IBs/RSI, ICFs, contraception language) and represent Patient Safety at internal/external meetings.
- Co-develop safety strategy and author safety sections for regulatory filings/MAAs (e.g., safety table shells, ISS, SCS, clinical overview, briefing docs, initial labeling: USPI/CCDS/SmPC); lead responses to ad hoc regulatory safety requests.
- Create/update EDSR; provide leadership/accountability for global/EU Risk Management Plans (RMPs); oversee additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally.
- Oversee a global safety/risk management team; drive digital/AI-enabled efficiency; support inspections/audits.
Degree & Experience Requirements
- Scientific degree (BS/MS/RN/PharmD/PhD/MD) or equivalent education + relevant experience.
- Minimum 8 years relevant pharmacovigilance/pharma industry/drug development experience; demonstrated ability to mentor/coach.
Key Competencies
- Safety strategy execution; strong scientific/medical synthesis of complex data; sound judgment; matrix leadership; adaptability; use of AI/automation/digital tools with scientific rigor.
Compensation/Benefits (as stated)
- Madison–Giralda–NJ (US): $217,520–$263,577 base range; additional incentive opportunities may be available.
Application Instructions
- If the role doesn’t fully match your resume, apply anyway.