Director, Medical Evaluation & Case Processing Oversight

CSL Limited

Multiple Locations
**
Global pharmacovigilance database knowledge
Proficient knowledge of regulatory rules
Oversight of medical evaluators
** CSL Limited is seeking a Director of Medical Evaluation & Case Processing Oversight with extensive experience in clinical trial and pharmacovigilance management. The role involves overseeing case processing in a global pharmacovigilance database, ensuring compliance with regulatory standards, and leading process optimization initiatives. **

Job Summary

  • Oversees all areas of single case processing in the global pharmacovigilance database from all sources, ensuring vendor compliance with regulatory guidelines and company SOPs.
  • Develops standards and processes with a focus on global compliance and process optimization, including medical review of serious and non-serious ICSRs.
  • Drives department-wide planning, owns case management dashboards, prepares for inspections, and leads transformation initiatives such as vendor transitions and digital tools.

Matching Summary

Match Score: 75

** CSL Limited is seeking a Director of Medical Evaluation & Case Processing Oversight with extensive experience in clinical trial and pharmacovigilance management. The role involves overseeing case processing in a global pharmacovigilance database, ensuring compliance with regulatory standards, and leading process optimization initiatives. **

Skills & Requirements

Must-have

  • Global pharmacovigilance database knowledge
  • Proficient knowledge of regulatory rules
  • Oversight of Medical Evaluators
  • Medical review of ICSRs
  • Process optimization

Nice-to-have

  • Agile team environment
  • Biotech ecosystems
  • Innovation and transformation initiatives
  • Collaboration with cross-functional teams

Key Requirements

  • 10 years of Clinical Trial and Post-marketing Pharmacovigilance experience
  • 5 years of managerial/leadership experience
  • BS/BA, RN, Pharmacist, or similar

Work Rights

Not specified

Tailored Resume

Cover Letter