Director, Medical Evaluation & Case Processing Oversight

CSL Behring

Multiple Locations
On-site
Global pharmacovigilance database knowledge
Global and local regulatory rules
Medical review of icsrs
CSL Behring is seeking a Director of Medical Evaluation & Case Processing Oversight to enhance its pharmacovigilance operations. The role involves overseeing case processing, ensuring compliance with regulatory standards, and leading a team of Medical Evaluators

Job Summary

  • You will oversee all areas of single case processing in the global pharmacovigilance database from all sources, ensuring vendor compliance with regulatory guidelines and company SOPs.
  • This role develops standards and processes with a focus on global compliance and process optimization, and oversees Medical Evaluators responsible for medical review of ICSRs.
  • Key responsibilities include driving department-wide planning, owning case management dashboards, preparing for inspections, leading transformation initiatives, and piloting innovations.

Matching Summary

Match Score: 85

CSL Behring is seeking a Director of Medical Evaluation & Case Processing Oversight to enhance its pharmacovigilance operations. The role involves overseeing case processing, ensuring compliance with regulatory standards, and leading a team of Medical Evaluators.

Skills & Requirements

Must-have

  • Global pharmacovigilance database knowledge
  • Global and local regulatory rules
  • Medical review of ICSRs
  • Oversight of Case Management Processes

Nice-to-have

  • Agile team
  • Process optimization
  • Digital tools
  • RPA, AI triage, tech integration

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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