Auditor - Pv

CSL Behring

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Pharmacovigilance audit execution
Gvp regulatory knowledge
Capa development and implementation
** CSL Behring is seeking an experienced Pharmacovigilance (PV) Auditor to execute global audits and ensure compliance with drug safety regulations. The role involves conducting audits, identifying non-compliance trends, and maintaining knowledge of global pharmacovigilance practices. **

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.
  • Candidates must possess excellent interpersonal skills to work effectively with multinational teams and external suppliers across different regions.

Matching Summary

Match Score: 75

** CSL Behring is seeking an experienced Pharmacovigilance (PV) Auditor to execute global audits and ensure compliance with drug safety regulations. The role involves conducting audits, identifying non-compliance trends, and maintaining knowledge of global pharmacovigilance practices. **

Skills & Requirements

Must-have

  • Pharmacovigilance audit execution
  • GVP regulatory knowledge
  • CAPA development and implementation
  • Risk categorization of findings
  • External vendor auditing

Nice-to-have

  • Collaborative stakeholder engagement
  • Multinational team experience
  • Strong negotiation skills
  • Trend analysis capabilities
  • SOP improvement initiatives

Key Requirements

  • BS degree in biological science, pharmacy, or related field
  • Quality Assurance experience in GVP-regulated environment
  • Experience in audit and inspection management
  • Ability to travel up to 50%

Work Rights

Not specified

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