Pharmacovigilance Specialist

Job Summary

To support pharmacovigilance activities, the full-time Pharmacovigilance Specialist will manage safety monitoring and compliance tasks for medicinal and non-medicinal products, working in a hybrid environment based in Croatia.

Key responsibilities

• Monitor local and EU pharmacovigilance legislation and notify relevant stakeholders
• Collect and assess Individual Case Safety Reports (ICSRs) and maintain documentation records
• Prepare and submit Periodic Safety Update Reports (PSURs) and cooperate with the EU QPPV on signal management activities

Required qualifications

• B.Sc./B.A. or higher degree in medicine, pharmacy, dental medicine, medical biochemistry, or veterinary medicine
• At least two years of experience in pharmacovigilance
• Advanced knowledge of local legislation relevant to pharmacovigilance activities
• Good clinical practice certificate
• Expertise in medicine, pharmaceutical sciences, epidemiology, or biostatistics