Associate Director, Patient Safety Scientist
Core
Strategic advisor and key partner to the Safety Management Team (SMT) Chair, responsible for characterizing conditions for safe use of medicines, driving signal detection, and ensuring pharmacovigilance regulatory compliance.
Role type
Senior IC Patient Safety Scientist (Associate Director)
Builds
Safety strategies, risk management plans, and regulatory documentation for assets in development and marketed products.
Domain
Pharmaceutical industry / Pharmacovigilance / Regulatory Affairs
Required skills
Signal detection and assessment, Safety data review and evaluation, Medical writing for regulatory documents, Risk management planning, Cross-functional collaboration, Team leadership and mentoring, Regulatory compliance knowledge, Data analysis and interpretation, Strategic decision-making, Automation and digital tool utilization
Preferred skills
Experience with AI and emerging technologies, Understanding of epidemiology and non-interventional research (NIR), Knowledge of in-licensing arrangements and pharmacovigilance agreements
Technologies
Signal management systems, Health authority/claims databases, AI-generated outputs, Digital platforms
Responsibilities
Lead Safety Data Review Meetings (SDRMs) and drive core signal detection activities, Author comprehensive signal reports and safety sections of aggregate safety documents (DSUR, PBRER, PADER), Lead preparation of safety sections in clinical trial documents (protocols, CSRs, IBs), Create and update global and EU Risk Management Plans (RMPs), Provide strategic input for regulatory filings and marketing authorization applications, Mentor less experienced scientists in safety and risk management.
Seniority
Senior, hands-on IC with strategic leadership