Director, Patient Safety Scientist
Bristol Myers Squibb
June 29, 2026
Remote friendly (Princeton, NJ)
United States
Medical Affairs
Position Summary
Director, Patient Safety Scientist partners with MSAP/SMT Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence by evaluating and mitigating risks.
Responsibilities
- Develop/co-develop global safety strategy with SMT Chair; oversee signal detection/assessment across product lifecycle for multiple compounds.
- Lead signal evaluation (case-series, literature review, health authority/claims databases); drive cross-functional signal reports, conclusions, tracking, engagement, and documentation.
- Provide medical writing for safety/risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER).
- Develop strategy, analyze data, and write ad hoc health authority responses; support local market risk queries; mentor scientists.
- Lead safety sections for clinical documents (protocols, CSRs, IBs/RSI, ICFs, contraception language); represent Patient Safety in meetings.
- Co-develop safety strategy and author safety sections for regulatory filings (MAA; ISS, SCS, labeling: USPI/CCDS/SmPC); lead responses to ad hoc regulatory safety requests (e.g., 120-day updates).
- Support safety labeling updates and EU QPPV/regional QP needs.
- Create/update EDSR strategy; lead global/EU Risk Management Plans (RMPs); lead core additional RMMs/aPVAs and guide local markets/vendors.
- Oversee global safety team; drive digital/AI-enabled improvements; support regulatory inspections/audits; foster excellence and continuous improvement.
Qualifications & Skills
- Scientific degree (BS, MS, RN, PharmD, PhD, MD or equivalent).
- 8+ years relevant pharmacovigilance/pharma/drug development experience; ability to mentor/coach.
- Ability to develop/execute safety strategy across complex cross-functional initiatives.
- Strong scientific/medical expertise to synthesize clinical/nonclinical/postmarketing/literature data.
- Sound judgment, decision-making, and matrix leadership; strong facilitation and communication.
- Adaptable; incorporates AI/automation/digital tools while maintaining rigor and compliance.
Compensation & Benefits (as stated)
- Princeton, NJ, US: $217,520–$263,577.
- Health coverage (medical/pharmacy/dental/vision); 401(k); disability and life insurance.
Work-life
- Flexible time off (US exempt) or annual paid vacation (Phoenix/Puerto Rico/Rayzebio non-exempt/hourly), plus national holidays.
Director, Patient Safety Scientist partners with MSAP/SMT Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence by evaluating and mitigating risks.
Responsibilities
- Develop/co-develop global safety strategy with SMT Chair; oversee signal detection/assessment across product lifecycle for multiple compounds.
- Lead signal evaluation (case-series, literature review, health authority/claims databases); drive cross-functional signal reports, conclusions, tracking, engagement, and documentation.
- Provide medical writing for safety/risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER).
- Develop strategy, analyze data, and write ad hoc health authority responses; support local market risk queries; mentor scientists.
- Lead safety sections for clinical documents (protocols, CSRs, IBs/RSI, ICFs, contraception language); represent Patient Safety in meetings.
- Co-develop safety strategy and author safety sections for regulatory filings (MAA; ISS, SCS, labeling: USPI/CCDS/SmPC); lead responses to ad hoc regulatory safety requests (e.g., 120-day updates).
- Support safety labeling updates and EU QPPV/regional QP needs.
- Create/update EDSR strategy; lead global/EU Risk Management Plans (RMPs); lead core additional RMMs/aPVAs and guide local markets/vendors.
- Oversee global safety team; drive digital/AI-enabled improvements; support regulatory inspections/audits; foster excellence and continuous improvement.
Qualifications & Skills
- Scientific degree (BS, MS, RN, PharmD, PhD, MD or equivalent).
- 8+ years relevant pharmacovigilance/pharma/drug development experience; ability to mentor/coach.
- Ability to develop/execute safety strategy across complex cross-functional initiatives.
- Strong scientific/medical expertise to synthesize clinical/nonclinical/postmarketing/literature data.
- Sound judgment, decision-making, and matrix leadership; strong facilitation and communication.
- Adaptable; incorporates AI/automation/digital tools while maintaining rigor and compliance.
Compensation & Benefits (as stated)
- Princeton, NJ, US: $217,520–$263,577.
- Health coverage (medical/pharmacy/dental/vision); 401(k); disability and life insurance.
Work-life
- Flexible time off (US exempt) or annual paid vacation (Phoenix/Puerto Rico/Rayzebio non-exempt/hourly), plus national holidays.