Director, Medical Evaluation & Case Processing Oversight

CSL

10 years clinical trial experience
5 years managerial leadership experience
Global pharmacovigilance database knowledge
This role oversees all areas of single case processing in the global pharmacovigilance database ensuring adherence to regulatory guidelines and company SOPs

Job Summary

  • This role oversees all areas of single case processing in the global pharmacovigilance database ensuring adherence to regulatory guidelines and company SOPs.
  • The position involves developing standards for medical evaluation of ICSRs including seriousness, listedness, and causality assessments while managing a team of Medical Evaluators.
  • Joining CSL offers the opportunity to lead transformation initiatives such as digital tools integration and represent PV case management in global regulatory initiatives.

Matching Summary

This role oversees all areas of single case processing in the global pharmacovigilance database ensuring adherence to regulatory guidelines and company SOPs.

Skills & Requirements

Must-have

  • 10 years clinical trial experience
  • 5 years managerial leadership experience
  • Global pharmacovigilance database knowledge
  • Medical review of serious cases
  • Regulatory compliance oversight

Nice-to-have

  • Experience with RPA and AI triage
  • Digital transformation initiatives
  • Vendor transition management
  • Cross-functional collaboration skills
  • Innovation pilot leadership

Key Requirements

  • Minimum 10 years Pharmacovigilance experience
  • Minimum 5 years managerial experience
  • BS/BA, RN, Pharmacist, or similar degree
  • Proficient knowledge of global regulatory rules

Work Rights

Not specified

Tailored Resume

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