Auditor - Pv

CSL Seqirus

Not specified
Pharmacovigilance audit execution
Gvp regulatory knowledge
Drug safety operations experience
CSL Seqirus is seeking a PV Auditor to enhance their Research & Development Quality audit program, focusing on compliance and safety data accuracy within pharmacovigilance. The ideal candidate should have strong audit experience in a GVP-regulated environment, excellent communication skills, and the ability to work collaboratively across teams

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 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 PV Auditor to enhance their Research & Development Quality audit program, focusing on compliance and safety data accuracy within pharmacovigilance. The ideal candidate should have strong audit experience in a GVP-regulated environment, excellent communication skills, and the ability to work collaboratively across teams.

Skills & Requirements

Must-have

  • Pharmacovigilance audit execution
  • GVP regulatory knowledge
  • Drug safety operations experience
  • CAPA development skills
  • Risk categorization expertise

Nice-to-have

  • Multinational team collaboration
  • Negotiation with external suppliers
  • Systemic risk identification
  • SOP improvement initiatives

Key Requirements

  • BS degree in biological science or pharmacy
  • Quality Assurance experience in GVP-regulated environment
  • Audit and inspection management expertise
  • Ability to travel up to 50%

Work Rights

Not specified

Tailored Resume

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