Director, Medical Evaluation & Case Processing Oversight

CSL SEQIRUS

Multiple Locations
Global pharmacovigilance database knowledge
Global and local regulatory rules
Oversight of single case processing
CSL's R&D organization is accelerating innovation to deliver greater impact for patients, building a future-ready team that thrives in dynamic biotech ecosystems

Job Summary

  • CSL's R&D organization is accelerating innovation to deliver greater impact for patients, building a future-ready team that thrives in dynamic biotech ecosystems.
  • You will oversee all areas of single case processing in the global pharmacovigilance database from all sources, ensuring vendor compliance and developing standards for global compliance and process optimization.
  • This role drives department-wide planning, prepares for inspections, leads transformation initiatives, monitors regulatory trends, and pilots innovations like RPA and AI triage.

Matching Summary

CSL's R&D organization is accelerating innovation to deliver greater impact for patients, building a future-ready team that thrives in dynamic biotech ecosystems.

Skills & Requirements

Must-have

  • Global pharmacovigilance database knowledge
  • Global and local regulatory rules
  • Oversight of single case processing
  • Medical review of ICSRs
  • Vendor performance management

Nice-to-have

  • Agile team environment
  • Patient impact focus
  • Collaboration and innovation
  • Digital tool integration

Key Requirements

  • Minimum 10 years PV experience
  • Minimum 5 years managerial experience
  • BS/BA, RN, or Pharmacist degree

Work Rights

Not specified

Tailored Resume

Cover Letter