Quality Assurance Auditor (PV)
Primary Location: Poland, Remote Additional Locations: Czech Republic, Prague; Estonia, Remote; Latvia, Remote; Lithuania, Vilnius; Romania, Bucharest; Serbia, Belgrade; United Kingdom, Remote Job ID R0000034517 Category Quality ManagementAbout this Role
Quality Assurance Auditor - Pharmacovigilance/Safety Specialist
We have an exciting opportunity for an experienced Quality Assurance Auditorwith a strong background insafety and pharmacovigilance(PV) to join our team in selected European countries.
This pivotal role will allow you to leverage your expertise in GxP compliance and PV systems to ensure the highest standards of quality and regulatory compliance across our clinical research operations.
Key Responsibilities
- Lead pharmacovigilance/safety audits across clinical research phases
- Independently plan, conduct, and report GxP audits including for-cause and client co-audits
- Review audit findings and ensure adequate CAPA implementation
- Support Serious Breaches investigations and reportability determinations
- Provide expert consultation on safety/PV regulatory compliance
- Mentor junior auditors and potentially lead audit programs
Requirements
- Significant experience in (PV) pharmacovigilance/safety quality assurance and GxP auditing
- In-depth knowledge of international clinical trial regulations and safety reporting requirements
- Strong analytical skills with attention to detail while maintaining strategic perspective
- Excellent communication skills and ability to manage multiple projects
- Experience with Trial Master File audits and safety documentation review
Education
- Bachelor’s Degree or other relevant experience required. Life-science, health or industry-related discipline preferred
Are you passionate about ensuring excellence in pharmacovigilance and safety practices? Join our team and help shape the future of clinical research quality assurance!
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