Director, Medical Evaluation & Case Processing Oversight
CSL Behring
Global pharmacovigilance database knowledge
Medical review of serious icsrs
Vendor performance oversight in pv
This role oversees all areas of single case processing in the global pharmacovigilance database to ensure regulatory compliance and patient safety
Job Summary
This role oversees all areas of single case processing in the global pharmacovigilance database to ensure regulatory compliance and patient safety.
The position involves developing standards and processes while managing a team of Medical Evaluators responsible for reviewing complex adverse event reports.
Joining CSL offers the opportunity to work within an agile, future-ready team committed to delivering innovative therapies worldwide.
Matching Summary
This role oversees all areas of single case processing in the global pharmacovigilance database to ensure regulatory compliance and patient safety.
Skills & Requirements
Must-have
Global pharmacovigilance database knowledge
Medical review of serious ICSRs
Vendor performance oversight in PV
Regulatory compliance with global rules
Process optimization for case management
Nice-to-have
Experience with RPA and AI triage tools
Leadership in transformation initiatives
Collaboration across Clinical and QA functions
Innovation pilot execution skills
Key Requirements
Minimum 10 years Clinical Trial and Post-marketing Pharmacovigilance experience
5 years of managerial or leadership experience required
BS/BA, RN, Pharmacist, or similar degree qualification