Senior Pharmacovigilance Officer (ICSR Management)

About the role

Ergomed is hiring a senior Pharmacovigilance Officer in Belgrade. The role sits within Ergomed's ICSR Management function and involves processing safety reports and supporting pharmacovigilance activities on behalf of its clients. The officer works as part of a project team, covering the full workflow cycle except Medical Review, and may mentor junior colleagues.

Key responsibilities

• Process Individual Case Safety Reports from all sources (post-marketing and clinical trials, including devices and combination products) in line with regulations, company procedures and client requirements and timelines
• Manage independent SAE/SUSAR submissions, unblinding and clinical trial reconciliations
• Prepare database outputs for periodic reporting such as PBRER, DSUR and PADER
• Mentor and train new and junior employees, including procedure optimisation and development

Required profile

• Life sciences or biomedical degree (chemistry, biology, biotechnology, veterinary science or similar healthcare-related field)
• Demonstrated experience in pharmacovigilance case processing, with several years' experience
• Ability to work in teams of different sizes, from small clinical trial to large generic post-marketing teams

Required skills

• Time and issue management, delegation, organisation and multitasking with good attention to detail
• Strong interpersonal and communication skills
• Advanced English, verbal and written, at least C1