Associate Director, Patient Safety Scientist
Core
Strategic advisor and key partner to the Safety Management Team to characterize conditions for safe use of medicines, detect safety signals, and influence decision-making for assets in development and marketed products.
Role type
Senior IC Patient Safety Scientist (Associate Director)
Builds
Safety strategies, signal detection reports, aggregate safety documents (DSUR, PBRER), Risk Management Plans (RMPs), and regulatory submissions.
Domain
Pharmaceutical industry / Pharmacovigilance / Clinical Development
Required skills
Signal detection and assessment, Safety data review and evaluation, Medical writing for safety documents, Regulatory compliance (PV), Risk management planning, Cross-functional collaboration, Mentorship of scientists, Data analysis and interpretation, Strategic decision-making, Understanding of clinical trial documentation.
Preferred skills
Experience with automation and AI tools for safety workflows, Knowledge of epidemiology and non-interventional research (NIR), Experience with complex Risk Minimization Measures (aRMMs).
Technologies
Safety data systems, Health authority/claims databases, AI-generated outputs, Digital platforms for safety.
Responsibilities
Drive core signal detection and assessment activities throughout the product life cycle; Lead Safety Data Review Meetings (SDRMs) and escalate program issues; Execute strategy for signal evaluation and author comprehensive signal reports; Provide strategic input for safety sections in clinical trial documents (protocols, CSRs, IBs); Author safety sections of marketing authorization applications (MAA) and labeling; Lead creation and maintenance of global Risk Management Plans (RMPs); Support regulatory inspections and audits.
Seniority
Senior, hands-on IC with strategic leadership