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Local Contact Person For Pharmacovigilance And Regulatory Affairs (Lcppv/Lcpra) - English & Dutch

2-3 years
Not Disclosed
10 July 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.