Not specified (assumed to be hybrid based on the nature of the auditing role and potential travel).
Pharmacovigilance audit execution
Gvp regulatory knowledge
Capa development and risk categorization
CSL Seqirus is seeking an experienced Pharmacovigilance Auditor to conduct audits, ensure compliance with safety data regulations, and support continuous improvement initiatives in drug safety. The ideal candidate will have a strong background in quality assurance within GVP-regulated environments and excellent communication skills to collaborate effectively with international teams
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: 85
CSL Seqirus is seeking an experienced Pharmacovigilance Auditor to conduct audits, ensure compliance with safety data regulations, and support continuous improvement initiatives in drug safety. The ideal candidate will have a strong background in quality assurance within GVP-regulated environments and excellent communication skills to collaborate effectively with international teams.
Skills & Requirements
Must-have
Pharmacovigilance audit execution
GVP regulatory knowledge
CAPA development and risk categorization
External vendor auditing experience
Trend analysis for non-compliance
Nice-to-have
Collaborative stakeholder management
Multinational team interaction
SOP improvement initiatives
Negotiation skills with suppliers
Key Requirements
BS degree in biological science, pharmacy, or related discipline
Quality Assurance experience within GVP-regulated environment