Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) – Remote | PrimeVigilance
Job Summary:
PrimeVigilance, a global leader in pharmacovigilance and regulatory affairs services, is seeking a Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA). This fully remote role supports marketing authorisation holders (MAHs) in maintaining product compliance throughout the lifecycle. The ideal candidate is fluent in English and Dutch with a background in GVP, regulatory intelligence, ADR reporting, and national pharmacovigilance systems. Join a multicultural, people-first organization making a direct impact on patient safety worldwide.
Key Responsibilities:
Serve as the main local contact for regulatory authorities regarding Pharmacovigilance (PV) and Regulatory Affairs (RA)
Manage ADR collection and reporting (e.g., ICSRs, follow-ups, translations)
Perform risk minimization oversight for urgent safety issues and restrictions
Provide local regulatory intelligence and expert advice
Oversee local pharmacovigilance systems in compliance with global and national standards
Conduct local literature screening and safety surveillance via health authority websites
Support preparation of regulatory documentation and submissions
Contribute to mock-up reviews, linguistic input, and local product information updates
Assist in audits, inspections, and local QA tasks (e.g., quality alerts, falsified products)
Collaborate closely with RA and PV global operations teams
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences, Chemistry, Nursing, or equivalent experience
Minimum 3 years in the pharmaceutical or CRO industry or a regulatory authority
At least 2 years in a local PV role (LCPPV) or similar safety-related position
Solid understanding of ICH GVP and local regulatory frameworks
Proficiency in English and Dutch (written and verbal)
Experience in Microsoft Office (Word, Excel, PowerPoint)
Previous Regulatory Affairs experience preferred but not required
Strong interpersonal, organizational, and documentation skills
Perks & Benefits:
Fully remote position with global team collaboration
Comprehensive training and career development programs
Strong focus on personal and professional growth
Supportive and inclusive work culture
Work in a company that values integrity, quality, agility, and collaborative partnerships
Exposure to international pharmacovigilance projects and global health impact
Company Description:
PrimeVigilance, part of the Ergomed Group, is a global pharmacovigilance and regulatory affairs service provider working with biotechnology and pharmaceutical clients across all therapeutic areas. With a robust global team and focus on compliance, safety, and integrity, PrimeVigilance supports life-saving medicines and devices worldwide.
Work Mode:
Remote
Call-to-Action:
Are you fluent in Dutch and English with a passion for pharmacovigilance and compliance? Apply now to join PrimeVigilance as a Remote LCPPV/LCPRA and help us make a global impact on patient safety and regulatory excellence.
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