Auditor - Pv

CSL Seqirus

**
Gvp-regulated environment experience
Pharmacovigilance audit execution
Capa development and risk categorization
** CSL Seqirus is seeking a Pharmacovigilance Auditor to support their Research & Development Quality audit program by ensuring compliance with safety data regulations and conducting audits of internal processes and external partners. The ideal candidate should have a background in quality assurance within a GVP-regulated environment, strong communication skills, and the ability to manage travel commitments. **

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 reliability of the pharmacovigilance system.
  • CSL Seqirus is part of CSL, 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: 75

** CSL Seqirus is seeking a Pharmacovigilance Auditor to support their Research & Development Quality audit program by ensuring compliance with safety data regulations and conducting audits of internal processes and external partners. The ideal candidate should have a background in quality assurance within a GVP-regulated environment, strong communication skills, and the ability to manage travel commitments. **

Skills & Requirements

Must-have

  • GVP-regulated environment experience
  • Pharmacovigilance audit execution
  • CAPA development and risk categorization
  • Global regulatory knowledge maintenance

Nice-to-have

  • Collaborative stakeholder engagement skills
  • Multinational team management ability
  • Strong analytical problem-solving skills

Key Requirements

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

Work Rights

Not specified

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