Local Contact Person - Pharmacovigilance and Regulatory Affairs

About the role

Ergomed is looking for a Specialist, Local RA & PV Network to act as the Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA). The role is the primary local representative for Regulatory Affairs and Pharmacovigilance, ensuring compliance with national requirements and supporting the Marketing Authorisation Holder (MAH) in keeping products compliant throughout their lifecycle. The position is full-time and open to permanent or contractor arrangements.

Key responsibilities

• Prompt and effective communication with the MAH and local regulatory authorities as required
• Serve as the primary contact for Regulatory Affairs and Pharmacovigilance with local authorities
• Provide local regulatory intelligence screening and expert advice for the responsible region(s)
• Collect and report locally suspected ADRs or ICSRs (FUs, translations)
• Manage and oversee risk minimization measures for urgent safety restrictions and emerging safety issues
• Support the development and implementation of the local pharmacovigilance system in line with the Global MAH's system and local regulations
• Perform local non-indexed literature screening and screen regulatory authority websites for potential ADRs and safety information
• Maintain accurate local records and documentation, and prepare documentation for regulatory submissions
• Provide review and linguistic input on local Product Information and mock-ups
• Support audits and inspections, and handle local QA tasks such as suspected falsified products and quality alerts from health authorities
• Support the RA & PV Global operations team

Required profile

• Bachelor's degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
• At least 3 years of pharmacovigilance or safety-related experience in a pharmaceutical, CRO or regulatory environment
• Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure)
• Experience in case handling, literature screening or local PV activities preferred
• Prior Regulatory Affairs experience preferred but not mandatory
• Proficiency in English; additional languages are advantageous

Required skills

• Strong Microsoft Office skills, including Word, Excel and PowerPoint