Not specified (assumed hybrid due to potential travel requirements).
External audit of pharmacovigilance vendors
Internal self-inspections of safety processes
Risk categorization of audit findings
CSL Seqirus is seeking a Pharmacovigilance Auditor to execute global audits and ensure compliance with safety data regulations. The ideal candidate will have a strong background in quality assurance within a GVP-regulated environment and excellent communication skills, as the role involves significant collaboration and travel
Job Summary
This role serves as a PV Auditor responsible for executing the global audit plan to ensure 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 pharmacovigilance system.
CSL Seqirus is part of CSL, one of the largest influenza vaccine providers globally, 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 Auditor to execute global audits and ensure compliance with safety data regulations. The ideal candidate will have a strong background in quality assurance within a GVP-regulated environment and excellent communication skills, as the role involves significant collaboration and travel.
Skills & Requirements
Must-have
External audit of pharmacovigilance vendors
Internal self-inspections of safety processes
Risk categorization of audit findings
CAPA development for drug safety
Trend analysis of non-compliance issues
Knowledge of global GVP regulations
Nice-to-have
Collaborative stakeholder engagement skills
Ability to work with multinational teams
Strong analytical problem-solving abilities
Experience in systemic stability initiatives
Key Requirements
BS degree in biological science, pharmacy, or related discipline
Quality Assurance experience within GVP-regulated environment