Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Quality Assurance Auditor (PV)
Job ID R0000034517 , PolandQuality 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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