Patient Safety and Pharmacovigilance Specialist
Core
Execute international adverse event and pharmacovigilance activities to ensure regulatory compliance and improve patient outcomes.
Role type
Pharmacovigilance Specialist
Builds
Safety reports, compliance data, and adverse event logs for regulatory agencies
Domain
Pharmaceutical industry / Drug Safety
Required skills
Adverse event reporting, Argus Safety Database, regulatory compliance (FDA/ICH), root cause analysis, audit support, literature review, safety mailbox management, CAPA evaluation
Preferred skills
Advanced degree (BPharm, PharmD, RN, MD, MSc), Clinical Trials experience (phases 1-4), business development support
Technologies
Argus Safety Database, Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Monitor PV system and prepare monthly performance reports; Analyze periodic PV metrics including KPIs and quality incidents; Compile and trend compliance data and conduct gap analyses; Evaluate safety reports for completeness and accuracy; Support audit and inspection readiness; Provide training on adverse event reporting; Manage safety mailbox and coordinate medical evaluations; Author Safety Monitoring Plans and process adverse events in Argus; Review and submit safety reports to regulatory agencies; Conduct literature reviews for adverse event identification; Serve as PV subject matter expert and oversee staff
Seniority
Mid-level, hands-on IC
