Senior Manager, Pharmacovigilance Scientist
Core
Senior leader responsible for characterizing safe use of medicines, leading signal detection, managing safety data reviews, 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), Risk management planning, Cross-functional collaboration, Health authority communication, Data interpretation and statistics, Process improvement and automation, Team leadership, Strategic safety planning
Preferred skills
Experience with AI and automation tools, Knowledge of epidemiology and non-interventional research, Understanding of global health authority requirements
Technologies
Signal management systems, Clinical data tools, Regulatory submission platforms, AI and digital platforms
Responsibilities
Lead Safety Data Review Meetings (SDRMs) and escalate program issues, Execute signal detection strategies and author comprehensive signal reports, Prepare safety sections for regulatory filings and marketing authorization applications, Develop and maintain Risk Management Plans (RMPs) and Risk Minimization Measures, Collaborate on clinical trial safety documents and support regulatory inspections, Analyze safety data to support labeling updates and benefit/risk profiles
Seniority
Senior, hands-on IC with management responsibilities