Auditor - Pv

cslseqirus.co.nz

Not specified
Gvp-regulated environment experience
Pharmacovigilance audit expertise
Drug safety operations knowledge
CSL Seqirus is seeking an experienced Pharmacovigilance (PV) Auditor to ensure compliance with safety data regulations and improve operational resilience within their global drug safety network. The role involves conducting audits, developing risk assessments, and collaborating with stakeholders to enhance safety reporting processes

Job Summary

  • This role serves as a PV Auditor responsible for executing the global audit plan to ensure the 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 one of the largest influenza vaccine providers in the world, offering state-of-the-art production facilities across the U.S., U.K., and Australia.

Matching Summary

Match Score: 85

CSL Seqirus is seeking an experienced Pharmacovigilance (PV) Auditor to ensure compliance with safety data regulations and improve operational resilience within their global drug safety network. The role involves conducting audits, developing risk assessments, and collaborating with stakeholders to enhance safety reporting processes.

Skills & Requirements

Must-have

  • GVP-regulated environment experience
  • Pharmacovigilance audit expertise
  • Drug safety operations knowledge
  • CAPA development skills
  • 50% travel requirement

Nice-to-have

  • Multinational team collaboration
  • Risk-based solution development
  • Strong negotiation skills
  • Analytical problem-solving abilities

Key Requirements

  • BS degree in biological science or pharmacy
  • Quality Assurance experience in GVP-regulated environment
  • Experience in audit and inspection management
  • Up to 50% travel availability

Work Rights

Not specified

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