Not specified (potentially hybrid or onsite due to travel requirements).
Gvp-regulated environment experience
Pharmacovigilance audit execution
Risk categorization and capa development
CSL Seqirus is seeking a Pharmacovigilance (PV) Auditor to execute audits and ensure compliance with global safety regulations within their Research & Development Quality audit program. The ideal candidate will have strong audit experience and the ability to navigate complex safety environments while collaborating with stakeholders
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 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: 85
CSL Seqirus is seeking a Pharmacovigilance (PV) Auditor to execute audits and ensure compliance with global safety regulations within their Research & Development Quality audit program. The ideal candidate will have strong audit experience and the ability to navigate complex safety environments while collaborating with stakeholders.
Skills & Requirements
Must-have
GVP-regulated environment experience
Pharmacovigilance audit execution
Risk categorization and CAPA development
Trend analysis for non-compliance
50% travel requirement
Nice-to-have
Excellent negotiation skills
Multinational team collaboration
Strong analytical problem-solving
Continuous improvement initiatives
Key Requirements
BS degree in biological science or pharmacy
Quality Assurance experience in GVP-regulated environment