Director, Medical Evaluation & Case Processing Oversight
Century Center
Global pharmacovigilance database knowledge
Medical review of serious icsrs
Vendor performance oversight
This role oversees all areas of single case processing in the global pharmacovigilance database ensuring compliance with regulatory guidelines and company SOPs
Job Summary
This role oversees all areas of single case processing in the global pharmacovigilance database ensuring compliance with regulatory guidelines and company SOPs.
The position requires developing standards for medical review of serious cases, legal ICSRs, and combination products while managing a team of Medical Evaluators.
Joining CSL offers the opportunity to lead transformation initiatives such as vendor transitions and technology integration within an agile, future-ready team.
Matching Summary
This role oversees all areas of single case processing in the global pharmacovigilance database ensuring compliance with regulatory guidelines and company SOPs.
Skills & Requirements
Must-have
Global pharmacovigilance database knowledge
Medical review of serious ICSRs
Vendor performance oversight
Regulatory compliance with PV agreements
Process optimization and SOP development
Nice-to-have
Experience with RPA and AI triage tools
Digital transformation leadership skills
Cross-functional collaboration abilities
Innovation pilot project experience
Key Requirements
Minimum 10 years Clinical Trial and Post-marketing Pharmacovigilance experience