Pharmacovigilance Services Assoc Manager
Core
Lead medical review and safety surveillance for Individual Case Safety Reports (ICSRs) in the pharmaceutical industry, ensuring regulatory compliance and data accuracy.
Role type
Senior Individual Contributor (IC) Pharmacovigilance Associate Manager
Builds
Global Safety Database entries and regulatory safety submissions for pharmaceutical clients
Domain
Healthcare / Pharmacovigilance / Drug Safety
Required skills
Medical review of adverse events, MedDRA coding, causality assessment, SOP adherence, team training, client communication, data validation
Preferred skills
Experience with global regulatory requirements, cross-functional collaboration
Technologies
Global Safety Database, MedDRA
Responsibilities
Prioritize and prioritize medical review for ICSRs per client guidelines and SLAs; Verify adverse event selection, MedDRA coding, seriousness, labeling, and causality; Review source documents for medical accuracy; Write company causality comments and route cases; Lead training for internal and cross-functional teams; Advise on medical assessment queries from associates and reviewers; Validate data consistency in the safety database.