Senior Manager, Pharmacovigilance Scientist
Core
Characterize safe use of medicines by evaluating and mitigating risks, leading signal detection activities, and ensuring pharmacovigilance regulatory compliance.
Role type
Senior Manager, Pharmacovigilance Scientist
Builds
Safety assessments, signal reports, aggregate safety documents (DSUR, PBRER), Risk Management Plans (RMPs), and regulatory submission safety sections.
Domain
Pharmaceutical industry, Pharmacovigilance, Drug Safety
Required skills
Signal detection and assessment, Safety data review and analysis, Regulatory compliance (global HA requirements), Risk management planning, Clinical trial document safety review, Cross-functional collaboration, Data analysis and interpretation, Process improvement and automation
Preferred skills
Experience with AI and automation tools, Epidemiology collaboration, Non-interventional research (NIR) activities
Technologies
Signal management systems, Clinical data sources, Health authority/claims databases, AI generated outputs, Digital platforms
Responsibilities
Lead Safety Data Review Meetings (SDRMs) and escalate program issues, Execute strategy for signal evaluation and author comprehensive signal reports, Prepare safety sections for regulatory filings (MAA, ISS, SCS) and labeling updates, Develop and maintain global Risk Management Plans (RMPs) and Risk Minimization Measures, Contribute to clinical trial documents (protocols, CSRs, IBs) and support regulatory inspections.
Seniority
Senior Manager, strategic leadership & execution