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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.
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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
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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.
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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