Job Title: PV Auditor
Location: Remote
Employment Type: Full-time
Department: PV QA
About the Company:
PrimeVigilance, part of the Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. The company has consistently achieved global organic growth, with teams based in Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
PrimeVigilance is dedicated to providing exceptional support to pharmaceutical and biotechnology partners, building long-lasting relationships, and becoming a global leader in its field. The company covers all therapy areas, including medical devices.
PrimeVigilance values its employees by offering excellent training and development opportunities. The company emphasizes employee well-being, mental health, and work-life balance to ensure high-quality client service.
Job Responsibilities:
Manage and conduct internal and external (third-party) audits, ensuring compliance with PrimeVigilance's procedures, local/global regulatory requirements, and contractual agreements
Perform audits of PrimeVigilance’s partners, vendors/service providers, and internal processes
Document audit findings and recommendations, and identify process improvement opportunities, creating Audit reports within agreed formats and timelines
Serve as Co-Auditor for full Vendor and Internal System Audits, and Lead for Full PV Vendor Audits
Required Qualifications:
B.Sc. in Science, Nursing, or a related scientific field
Sufficient experience in pharmaceutical/biotech pharmacovigilance with a solid understanding of GVP-related Quality Management and Assurance
Adequate GxP auditing experience, with a proven ability in an Audit Lead role
In-depth knowledge of applicable GxP regulations (e.g., EU and FDA regulations, particularly EU GVP)
Strong analytical, written, and oral communication skills
Ability to manage tasks effectively, deliver expected results in a timely manner, and proactively communicate changes in goals and deadlines
Strategic thinking, with the ability to work collaboratively using risk-based, proactive problem-solving approaches
Strong team player
Proficiency in MS-Office applications (Word, Excel, PowerPoint)
Experience with EDMS systems (e.g., Veeva Vault, Master Control, Trackwise) is a plus
What We Offer:
Internal training and career development opportunities
Strong focus on personal and professional growth
A friendly, supportive working environment
The opportunity to collaborate with colleagues worldwide, with English as the company language
A company culture driven by core values:
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Australia | North York | Mississauga | Richmond Hill | Uxbridge | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Surabaya |Japan :
Saitama | Japan |Tokyo :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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