Job Title: PV Auditor
Location: Remote (Employees can work remotely)
Job Type: Full-time
Department: PV QA
About the Company:
PrimeVigilance, part of Ergomed Group, is a specialized pharmacovigilance service provider established in 2008. The company has experienced consistent global organic growth, with staff based across Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance serves pharmaceutical and biotechnology partners, becoming a global leader in its field. The company is committed to employee well-being, offering excellent training and development platforms, with a focus on work-life balance to ensure high-quality client service.
Job Responsibilities:
Audit Management:
Conduct internal and external (third-party) audits to ensure compliance with PrimeVigilance and client procedures, local and global regulatory requirements, and contractual agreements
Manage pre-audit activities effectively and conduct audits in line with the Audit Plan
Lead audits for PrimeVigilance’s partners, vendors, and service providers, as well as internal system audits
Audit Documentation and Reporting:
Document audit findings, provide recommendations, and identify process improvements in an agreed format and within set timelines
Serve as co-auditor for full vendor and internal system audits, and lead audits for full PV vendor audits
Required Qualifications:
Education:
B.Sc. in Science, Nursing, or a related scientific field
Experience:
Sufficient experience in pharmaceutical/biotech pharmacovigilance, with an understanding of GVP-related Quality Management and Assurance
Experience in GxP auditing, specifically in an Audit Lead role
Skills:
In-depth knowledge of GxP regulations (e.g., EU and FDA regulations, especially EU GVP)
Strong analytical, written, and oral communication skills
Ability to manage tasks efficiently, meet deadlines, and proactively communicate changes
Strategic thinking and risk-based, proactive problem-solving approach
Strong team player with proficiency in MS Office (Word, Excel, PowerPoint)
Knowledge of EDMS (e.g., Veeva Vault, Master Control, Trackwise) is a plus
Additional Information:
PrimeVigilance values diversity, equity, and inclusion, fostering an equal opportunities workplace where people from all cultural backgrounds, genders, and ages can thrive.
The company embraces a human-first approach, believing its people are its greatest strength in improving lives globally.
PrimeVigilance offers internal training, career development, and a friendly, supportive working environment with colleagues from around the world.
Core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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China | Quarry Bay |Hubei :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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North Ostrobothnia :
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Turku |France :
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Be'Er Sheva | Tel Aviv | Kfar Saba | Netanya | Yavne |Italy :
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Remote - Africa | Lenexa | Switzerland | Remote - Middle East | McFarland | Remote | Remote, USA | Melbourne | Remote - Europe | Remote - South America (Latin Americal) |Bucharest :
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