Director, Patient Safety Scientist
Core
Strategic advisor and leader for patient safety science, characterizing conditions for safe use of medicines and influencing decision-making for assets in development and marketed products.
Role type
Director, Patient Safety Scientist (Strategic IC)
Builds
Global safety strategies, risk management plans, regulatory safety documentation, and safety data review processes.
Domain
Pharmaceutical industry, Pharmacovigilance, Drug Development, Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Signal detection and assessment, Safety strategy development, Medical writing for regulatory documents, Data analysis (clinical, nonclinical, postmarketing), Cross-functional matrix leadership, Regulatory compliance knowledge, Risk management planning, Mentoring scientists
Preferred skills
Experience with AI/automation tools in safety workflows, Knowledge of epidemiology and non-interventional research (NIR), Experience with complex therapeutic areas
Technologies
Signal management systems, Health authority/claims databases, AI generated outputs, Digital platforms
Responsibilities
Develop global safety strategy and oversee signal detection across product lifecycle; Lead safety data review meetings and ensure regulatory compliance; Author safety sections for regulatory filings (MAA, ISS, SCS) and aggregate documents; Create and maintain Risk Management Plans (RMPs) and Risk Minimization Measures; Lead a global team of safety scientists and drive digital change initiatives.
Seniority
Director, Strategic Leadership & Team Management
