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.
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