Auditor - Pv

CSL Seqirus

Not specified
Gvp-regulated environment experience
External vendor audit execution
Drug safety operations knowledge
CSL Seqirus is seeking a Pharmacovigilance (PV) Auditor to execute global audits ensuring compliance with safety data regulations. The ideal candidate will possess a strong background in quality assurance within a GVP-regulated environment and have excellent 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 and non-compliance trends impacting the pharmacovigilance system.
  • CSL Seqirus is part of CSL, one of the largest influenza vaccine providers globally, offering 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 audits ensuring compliance with safety data regulations. The ideal candidate will possess a strong background in quality assurance within a GVP-regulated environment and have excellent communication skills.

Skills & Requirements

Must-have

  • GVP-regulated environment experience
  • External vendor audit execution
  • Drug safety operations knowledge
  • CAPA development and implementation
  • 50% travel requirement

Nice-to-have

  • Multinational team collaboration skills
  • Risk-based solution development
  • Strong negotiation abilities
  • Systemic stability focus

Key Requirements

  • BS degree in biological science or pharmacy
  • Quality Assurance experience in GVP-regulated environment
  • Audit and inspection management expertise
  • Experience with PSMF integrity protection

Work Rights

Not specified

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