Senior Pharmacovigilance Officer

About the role

Ergomed’s PrimeVigilance division is seeking a senior‑level Pharmacovigilance Officer to join its Zagreb team. You will be responsible for end‑to‑end processing of safety cases and will work closely with project teams serving both clinical trial and post‑marketing clients. The role offers the chance to contribute to patient safety while developing expertise in global PV regulations.

Key responsibilities

• Process Individual Case Safety Reports (ICSRs) from all sources, ensuring compliance with regulations, PrimeVigilance procedures, and client timelines.
• Manage independent SAE/SUSAR submissions, unblinding, and clinical trial reconciliations.
• Prepare database outputs for periodic safety reporting such as PBRER, DSUR, and PADER.
• Mentor and train junior team members, supporting procedure optimisation and development.

Required profile

• Life‑science or biomedical degree (e.g., chemistry, biology, biotechnology, veterinary science).
• Several years of demonstrated experience in pharmacovigilance case processing.
• Strong organisational, time‑management and multitasking abilities with high attention to detail.
• Excellent interpersonal and communication skills, with advanced English (C1 level or higher).

Required skills

• Pharmacovigilance case processing.
• SAE and SUSAR management.
• Database reporting for PBRER, DSUR, and PADER.