Associate Director, Patient Safety Scientist
Bristol Myers Squibb
August 29, 2026
Remote friendly (Madison, NJ)
United States
Medical Affairs
Position Summary
Associate Director, Patient Safety Scientist: Partner with the MSAP/SMT Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence by evaluating and mitigating risks. Independently perform core signal detection, lead safety data review meetings (SDRMs), and ensure pharmacovigilance regulatory compliance.
Duties & Responsibilities
- Drive core signal detection/assessment across the product life cycle using tools/data sources; lead SDRMs by reviewing clinical data and escalate key issues to the SMT Chair.
- Lead signal evaluation strategy and execution (case-series, literature review, health authority/claims databases); author signal reports; ensure tracking and documentation.
- Provide medical writing for safety/risk management sections of aggregate safety documents (DSUR, PBRER, PADER).
- Author ad hoc health authority responses (e.g., 120-day safety updates) and mentor other scientists.
- Lead safety input for clinical development documents (protocols, CSRs, IBs/RSI, ICFs, contraception language) and represent Patient Safety in meetings.
- Support regulatory filings and safety labeling updates (MAA/ISS/SCS/clinical overview/briefing book/USPI, CCDS, SmPC); support EU QPPV/other regional/local QP.
- Own risk management deliverables: EDSR, global/EU RMPs, aRMMs and aPVAs; support risk-minimization effectiveness and PASS activities.
- Leverage automation/innovation tools; support audits/inspections; drive cross-functional process improvements.
Education & Experience
- Scientific degree (BS, MS, RN, PharmD, PhD, MD) or equivalent combination.
- Minimum 6 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; ability to mentor.
Benefits (as stated)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support (EAP, wellbeing programs); financial protection (401(k), disability, life/accident insurance, etc.).
- Paid time off (includes flexible/unlimited PTO for US exempt; specified vacation/holidays for certain roles).
Associate Director, Patient Safety Scientist: Partner with the MSAP/SMT Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence by evaluating and mitigating risks. Independently perform core signal detection, lead safety data review meetings (SDRMs), and ensure pharmacovigilance regulatory compliance.
Duties & Responsibilities
- Drive core signal detection/assessment across the product life cycle using tools/data sources; lead SDRMs by reviewing clinical data and escalate key issues to the SMT Chair.
- Lead signal evaluation strategy and execution (case-series, literature review, health authority/claims databases); author signal reports; ensure tracking and documentation.
- Provide medical writing for safety/risk management sections of aggregate safety documents (DSUR, PBRER, PADER).
- Author ad hoc health authority responses (e.g., 120-day safety updates) and mentor other scientists.
- Lead safety input for clinical development documents (protocols, CSRs, IBs/RSI, ICFs, contraception language) and represent Patient Safety in meetings.
- Support regulatory filings and safety labeling updates (MAA/ISS/SCS/clinical overview/briefing book/USPI, CCDS, SmPC); support EU QPPV/other regional/local QP.
- Own risk management deliverables: EDSR, global/EU RMPs, aRMMs and aPVAs; support risk-minimization effectiveness and PASS activities.
- Leverage automation/innovation tools; support audits/inspections; drive cross-functional process improvements.
Education & Experience
- Scientific degree (BS, MS, RN, PharmD, PhD, MD) or equivalent combination.
- Minimum 6 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; ability to mentor.
Benefits (as stated)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support (EAP, wellbeing programs); financial protection (401(k), disability, life/accident insurance, etc.).
- Paid time off (includes flexible/unlimited PTO for US exempt; specified vacation/holidays for certain roles).