Local Pharmacovigilance Specialist

Job Summary

Acting as the primary local RA & PV representative, the full-time Local Pharmacovigilance Specialist will ensure compliance with national pharmacovigilance and regulatory requirements in Hungary, executing PV and RA activities while supporting the Marketing Authorisation Holder throughout the product lifecycle.

Key responsibilities

• Communicate promptly and effectively with the Marketing Authorisation Holder and local regulatory authorities
• Provide local regulatory intelligence and expert advice while managing risk minimization measures related to safety issues
• Collect and report locally suspected adverse drug reactions and maintain accurate local records and documentation

Required qualifications

• Bachelor's Degree in Life Sciences, 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
• Experience in case handling or local PV activities is preferred
• Proficiency in English; additional language knowledge is advantageous