Auditor - Pv

Csmlive

Not specified
Pharmacovigilance audit execution
Gvp regulatory knowledge
Risk categorization and capa
CSL Seqirus is seeking a Pharmacovigilance (PV) Auditor to ensure compliance with global drug safety standards through external and internal audits. The ideal candidate should have a strong background in quality assurance, particularly in GVP-regulated environments, along with excellent communication skills and the ability to manage audits and develop corrective actions

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 identifying non-compliance trends and systematic risks within the PV discipline to protect the integrity of the Pharmacovigilance System Master File.
  • CSL Seqirus is part of CSL, one of the largest influenza vaccine providers in the world, offering a culture focused on inclusion and belonging.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a Pharmacovigilance (PV) Auditor to ensure compliance with global drug safety standards through external and internal audits. The ideal candidate should have a strong background in quality assurance, particularly in GVP-regulated environments, along with excellent communication skills and the ability to manage audits and develop corrective actions.

Skills & Requirements

Must-have

  • Pharmacovigilance audit execution
  • GVP regulatory knowledge
  • Risk categorization and CAPA
  • External vendor auditing
  • 50% travel requirement

Nice-to-have

  • Multinational team collaboration
  • Systemic risk trend analysis
  • SOP improvement initiatives
  • Strong negotiation skills

Key Requirements

  • BS degree in biological science or pharmacy
  • Quality Assurance experience in GVP-regulated environment
  • Experience in audit and inspection management
  • Ability to work with limited supervision

Work Rights

Not specified

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