Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & Dutch
Location: Remote
Employment Type: Full-time
Department: Regulatory and PV Network
Company Overview:
PrimeVigilance, part of the Ergomed Group, is a specialized mid-sized pharmacovigilance service provider established in 2008. We offer comprehensive support across Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. With a global presence in Europe, North America, and Asia, we proudly partner with a range of pharmaceutical and biotechnology companies across all therapeutic areas, including medical devices.
We invest heavily in employee training and development and are committed to a work environment that values well-being, mental health, and a healthy work-life balance.
Job Summary:
The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) acts as the main local representative for regulatory and PV matters. This dual role ensures compliance with national requirements and supports the Marketing Authorisation Holder (MAH) throughout the product lifecycle.
Key Responsibilities:
Serve as the primary contact for local regulatory authorities regarding Regulatory Affairs and Pharmacovigilance.
Communicate promptly and effectively with authorities.
Provide expert advice and screen local regulatory intelligence.
Collect and report locally suspected ADRs or ICSRs, including follow-ups and translations.
Oversee local risk minimization measures and urgent safety restrictions.
Prepare and collect documents for submission to local regulatory bodies.
Review local Product Information and Mock-ups with linguistic accuracy.
Develop and implement a local pharmacovigilance system compliant with the global MAH system and local laws.
Conduct local non-indexed literature and regulatory website screenings for safety data.
Maintain accurate local records and documentation.
Support global RA & PV operations and ensure adherence to procedures.
Assist with audits and inspections.
Manage local QA tasks, including suspected falsified products and quality alerts.
Candidate Requirements:
Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent professional background.
Minimum 3 years of experience in the pharmaceutical/CRO industry or with a regulatory authority.
At least 2 years of experience in a relevant LCPPV role or pharmacovigilance position.
Training or experience in pharmacovigilance, per local regulations.
Prior Regulatory Affairs experience is a plus.
Solid knowledge of ICH GVP and relevant local legislation.
Fluent in both English and Dutch, written and spoken.
Proficient in Microsoft Office (Word, Excel, PowerPoint).
Why Join PrimeVigilance:
Opportunities for career development and internal training.
Supportive, inclusive, and international work culture.
Emphasis on collaboration, integrity, quality, and belonging.
Work with global teams using English as the company language.
We value diversity, inclusion, and a people-first approach. If you share our core values of Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships, we invite you to apply and join us on our mission to improve patient lives.
Estimated Salary: €55,000 – €75,000 annually (based on industry standards for remote PV/RA roles in the EU)
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Madrid |Cebu Province :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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