Pharmacovigilance and Regulatory Affairs Specialist

About the role

Ergomed is looking for a Specialist, Local Regulatory and PV network to act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA). The role is the primary local RA & PV representative ensuring compliance with national pharmacovigilance and regulatory requirements, and supports the Marketing Authorisation Holder (MAH) in keeping products compliant throughout their lifecycle.

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

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