Associate Director, Patient Safety Scientist
Core
Strategic advisor and key partner to the Safety Management Team leading signal detection, risk management, and safety strategy for BMS medicines across the product lifecycle.
Role type
Senior IC Patient Safety Scientist (Associate Director)
Builds
Safety strategies, risk management plans, regulatory submissions, and aggregate safety documents for marketed and in-development assets.
Domain
Pharmaceutical industry / Pharmacovigilance / Regulatory Affairs
Required skills
Signal detection and assessment, medical writing for safety documents, regulatory compliance (PV), risk management planning, data analysis and interpretation, strategic leadership, cross-functional collaboration, mentoring.
Preferred skills
Experience with automation and AI tools for safety workflows, understanding of epidemiology and non-interventional research (NIR).
Technologies
Signal detection tools, health authority/claims databases, aggregate safety document systems, digital platforms for safety data.
Responsibilities
Lead safety data review meetings (SDRMs), author safety sections for regulatory filings (MAA, DSUR, PBRER), develop and maintain global Risk Management Plans (RMPs), analyze complex clinical and postmarketing data to inform benefit-risk profiles, mentor less experienced scientists.
Seniority
Senior, hands-on IC with strategic leadership