Director, Medical Evaluation & Case Processing Oversight

Seqirus

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 serious and non-serious cases while managing vendor relationships and driving process optimization.
  • Joining this team offers the opportunity to lead transformation initiatives such as digital tool integration and represent pharmacovigilance case management in global strategic 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 ICSRs
  • Regulatory compliance oversight
  • Vendor performance management

Nice-to-have

  • Experience with RPA and AI triage tools
  • Knowledge of MedDRA coding standards
  • Digital transformation initiative leadership
  • Cross-functional collaboration skills
  • Innovation in safety science processes

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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