Senior Manager, Pharmacovigilance Scientist
Core
Senior leader responsible for characterizing safe use of medicines, leading signal detection/management, and ensuring regulatory compliance for pharmacovigilance programs.
Role type
Senior Manager, Pharmacovigilance Scientist
Builds
Safety assessments, regulatory filings (MAA, DSUR, RMP), and risk management plans for pharmaceutical products.
Domain
Life Sciences / Pharmacovigilance / Regulatory Affairs
Required skills
Signal detection and assessment, Safety data review and analysis, Regulatory document authoring (DSUR, PBRER, RMP), Cross-functional collaboration, Risk management strategy, Health authority communication
Preferred skills
Automation and AI tool utilization, Epidemiology and non-interventional research, Process improvement
Technologies
Signal management systems, AI generated outputs, Digital platforms
Responsibilities
Lead Safety Data Review Meetings (SDRMs), Execute safety strategies for regulatory submissions, Develop and maintain Risk Management Plans (RMPs), Analyze safety data and write responses to health authorities, Support clinical trial safety documentation
Seniority
Senior, hands-on IC with management responsibilities