Associate Director of Pharmacovigilance - West Palm Beach Florida

Company: VirtualVocations
Location: West Palm Beach, Florida
Posted On: 02/06/2025

A company is looking for an Associate Director of Drug Safety and Pharmacovigilance Operations.



Key Responsibilities

Oversee EAP vendor compliance and safety data exchange agreements
Manage adverse event reconciliation and safety reporting for EAP countries
Serve as primary contact for PV requests and support regulatory inspections


Required Qualifications

Bachelor's degree in a relevant field or related experience
8+ years of experience in the biotechnology or pharmaceutical industry, including 4+ years in Pharmacovigilance operations
Expert knowledge of Argus or equivalent PV database
Strong understanding of regulatory guidelines and Good Documentation Practices
Experience in ICSR case-processing and reporting, with knowledge of MedDRA coding More...

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