Associate Director, Patient Safety Scientist
Bristol Myers Squibb
August 07, 2026
Remote friendly (Madison, NJ)
United States
Medical Affairs
Position: Associate Director, Patient Safety Scientist
Responsibilities
- Drive core signal detection/assessment across product lifecycle using tools/data sources; lead Safety Data Review Meetings (SDRMs) by reviewing clinical data and escalating key issues to the SMT Chair.
- Develop and execute signal evaluation strategy (e.g., case-series, literature review, health authority/claims databases); author signal reports; ensure tracking, stakeholder engagement, and documentation.
- Provide medical writing for safety/risk management sections of aggregate safety reports (e.g., DSUR, PBRER, PADER).
- Author ad hoc responses to health authorities (including supporting local markets) and mentor junior scientists.
- Lead/prepare safety sections for clinical trial documents (protocols, CSRs, IB/RSI, ICFs, contraception language) and represent Patient Safety in meetings.
- Execute safety strategy for regulatory filings (e.g., MAA and safety sections such as ISS, SCS, clinical overview, briefing book, labeling like USPI/CCDS/SmPC) and respond to regulatory safety updates (e.g., 120-day).
- Create/update EDSR; support Structured Benefit Risk; lead global/EU Risk Management Plans (RMPs).
- Lead creation/revisions of aRMMs and aPVAs globally and locally; guide markets/vendors.
- Use automation/digital improvements; support audits/inspections; drive cross-functional process improvement.
Qualifications
- Scientific degree (BS/MS/RN/PharmD/PhD/MD) or equivalent.
- Minimum 6 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; ability to mentor.
Benefits (highlights)
- Health coverage (medical/pharmacy/dental/vision); wellbeing support; 401(k) and disability/life insurance.
- Paid time off (flexible time off for US exempt employees; otherwise annual vacation per location).
Application
- If the role is of interest but doesn’t perfectly match your resume, apply anyway.
Responsibilities
- Drive core signal detection/assessment across product lifecycle using tools/data sources; lead Safety Data Review Meetings (SDRMs) by reviewing clinical data and escalating key issues to the SMT Chair.
- Develop and execute signal evaluation strategy (e.g., case-series, literature review, health authority/claims databases); author signal reports; ensure tracking, stakeholder engagement, and documentation.
- Provide medical writing for safety/risk management sections of aggregate safety reports (e.g., DSUR, PBRER, PADER).
- Author ad hoc responses to health authorities (including supporting local markets) and mentor junior scientists.
- Lead/prepare safety sections for clinical trial documents (protocols, CSRs, IB/RSI, ICFs, contraception language) and represent Patient Safety in meetings.
- Execute safety strategy for regulatory filings (e.g., MAA and safety sections such as ISS, SCS, clinical overview, briefing book, labeling like USPI/CCDS/SmPC) and respond to regulatory safety updates (e.g., 120-day).
- Create/update EDSR; support Structured Benefit Risk; lead global/EU Risk Management Plans (RMPs).
- Lead creation/revisions of aRMMs and aPVAs globally and locally; guide markets/vendors.
- Use automation/digital improvements; support audits/inspections; drive cross-functional process improvement.
Qualifications
- Scientific degree (BS/MS/RN/PharmD/PhD/MD) or equivalent.
- Minimum 6 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; ability to mentor.
Benefits (highlights)
- Health coverage (medical/pharmacy/dental/vision); wellbeing support; 401(k) and disability/life insurance.
- Paid time off (flexible time off for US exempt employees; otherwise annual vacation per location).
Application
- If the role is of interest but doesn’t perfectly match your resume, apply anyway.