Auditor - Pv

CSL SEQIRUS

Not specified (potentially hybrid or onsite due to audit responsibilities)
Pharmacovigilance audit execution
Gvp regulatory knowledge
Capa development and risk categorization
CSL Seqirus is seeking a Pharmacovigilance (PV) Auditor to execute global audit plans, ensuring compliance with safety data regulations and identifying non-compliance trends. The ideal candidate will bring experience in quality assurance within GVP-regulated environments and possess strong analytical and communication skills. ###

Job Summary

  • This role serves as a PV Auditor responsible for executing the global audit plan to ensure accuracy of safety data and compliance with legal standards.
  • The position requires conducting audits of external partners and internal safety functions to identify findings that could impact the reliability of the pharmacovigilance system.
  • CSL Seqirus is a major contributor to influenza prevention globally, utilizing state-of-the-art production facilities in the U.S., U.K., and Australia.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a Pharmacovigilance (PV) Auditor to execute global audit plans, ensuring compliance with safety data regulations and identifying non-compliance trends. The ideal candidate will bring experience in quality assurance within GVP-regulated environments and possess strong analytical and communication skills. ###

Skills & Requirements

Must-have

  • Pharmacovigilance audit execution
  • GVP regulatory knowledge
  • CAPA development and risk categorization
  • External vendor auditing experience
  • 50% travel requirement

Nice-to-have

  • Multinational team collaboration
  • Strong negotiation skills
  • Systemic risk trend analysis
  • SOP improvement initiatives

Key Requirements

  • BS degree in biological science or pharmacy
  • Quality Assurance experience in GVP-regulated environment
  • Audit expertise in pharmacovigilance discipline
  • Ability to manage schedule with up to 50% travel

Work Rights

Not specified

Tailored Resume

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