Senior Pharmacovigilance Associate (Medical Review)
Core
Conduct comprehensive medical reviews of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources to ensure safety of investigational drugs and regulatory compliance.
Role type
Senior Pharmacovigivance Associate (Medical Review)
Builds
Safety-related documents including periodic safety reports and risk management plans
Domain
Healthcare / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical review of adverse event reports, ICSR processing across therapeutic areas, risk management strategy development, safety database management (ARGUS), clinical/diagnostic assessment, regulatory compliance adherence
Preferred skills
Cross-functional collaboration, emerging safety literature analysis, technical leadership in Case Management
Technologies
ARGUS
Responsibilities
Provide medical review and assessment of adverse event reports, Conduct comprehensive ICSR medical reviews, Collaborate to develop risk management strategies, Contribute to preparation of periodic safety reports, Stay abreast of emerging safety concerns, Provide technical leadership within Case Management
Seniority
Senior, hands-on IC