Auditor - Pv

CSL Seqirus

Not specified (assumed to involve travel for audits)
Conduct external pv vendor audits
Execute internal safety process inspections
Develop comprehensive audit reports with risk categorization
CSL Seqirus is seeking a PV Auditor to execute global audits within their Research & Development Quality audit program, ensuring compliance with safety data standards. The ideal candidate should have experience in pharmacovigilance and quality assurance, along with strong communication and analytical skills

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 that could impact the reliability of the pharmacovigilance system.
  • CSL Seqirus is a major contributor to influenza vaccine prevention globally, utilizing state-of-the-art production facilities across the U.S., U.K., and Australia.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a PV Auditor to execute global audits within their Research & Development Quality audit program, ensuring compliance with safety data standards. The ideal candidate should have experience in pharmacovigilance and quality assurance, along with strong communication and analytical skills.

Skills & Requirements

Must-have

  • Conduct external PV vendor audits
  • Execute internal safety process inspections
  • Develop comprehensive audit reports with risk categorization
  • Identify non-compliance trends in drug safety
  • Maintain knowledge of global GVP regulations

Nice-to-have

  • Excellent interpersonal and negotiation skills
  • Ability to work with multinational teams
  • Strong analytical and problem-solving skills
  • Experience navigating complex safety environments
  • Collaborative approach to developing corrective actions

Key Requirements

  • BS degree in biological science, pharmacy, or related discipline
  • Quality Assurance experience within a GVP-regulated environment
  • Audit and inspection management experience in pharmacovigilance
  • Ability to manage schedule including up to 50% travel

Work Rights

Not specified

Tailored Resume

Cover Letter