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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: Remote 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

 

Remote LCPPV/LCPRA (English & Dutch) – Pharmacovigilance & Regulatory Affairs | PrimeVigilance

Job Summary:

PrimeVigilance, a leading global pharmacovigilance and regulatory affairs service provider, is hiring a Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA). This fully remote dual-role position is ideal for professionals fluent in English and Dutch, with proven experience in GVP compliance, ADR reporting, and national regulatory engagement. Join a human-centric team committed to patient safety, compliance, and global health.


Key Responsibilities:

  • Act as the main local contact for pharmacovigilance (PV) and regulatory authorities (RA)

  • Communicate promptly and effectively with local regulatory agencies

  • Provide expert insights through regulatory intelligence screening

  • Collect and report suspected ADRs/ICSRs including follow-ups and translations

  • Manage risk minimization measures and urgent safety restrictions

  • Prepare documentation and submissions to regulatory authorities

  • Review and contribute to product information and mock-ups

  • Maintain a compliant local PV system aligned with global MAH processes

  • Perform local literature screening and monitor authority websites for ADRs

  • Maintain accurate records and documentation

  • Support RA & PV global operations, audits, and inspections

  • Handle local QA tasks like falsified products or quality alerts


Required Skills & Qualifications:

  • Bachelor's degree in Life Sciences, Chemistry, Nursing, or equivalent

  • 3+ years in pharma/CRO/regulatory authority

  • 2+ years in pharmacovigilance or LCPPV role

  • Knowledge of ICH GVP and local PV regulations

  • Fluency in English and Dutch, both verbal and written

  • Strong in Microsoft Word, Excel, and PowerPoint

  • Prior experience in Regulatory Affairs (preferred but not mandatory)


Perks & Benefits:

  • Fully remote work model with global collaboration

  • Opportunities for training and career development

  • Supportive and inclusive work culture

  • Work in a diverse team with English as the primary language

  • Strong emphasis on employee well-being and work-life balance

  • Contribute to global healthcare and patient safety


Company Description:

PrimeVigilance, part of the Ergomed Group, is a globally recognized mid-size pharmacovigilance and regulatory services provider. With clients across the pharma, biotech, and medical device sectors, we deliver excellence in compliance and safety through innovation, collaboration, and scientific rigor.


Work Mode:

Remote


Call-to-Action:

Are you ready to use your Dutch and English expertise in a meaningful career impacting global patient safety? Apply now and join PrimeVigilance as a Remote LCPPV/LCPRA and make a difference in regulatory compliance and pharmacovigilance.