Quality Assurance Auditor (PV)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Quality Assurance Auditor - Pharmacovigilance/Safety Specialist

We have an exciting opportunity for an experienced Quality Assurance Auditor with a strong background in safety 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!