Senior Pharmacovigilance Officer
PrimeVigilance · Belgrade
Description du poste
About the role
PrimeVigilance is seeking a senior‑level Pharmacovigilance Officer to join its global safety team. You will work on diverse case‑processing projects, ranging from early‑stage clinical trials to large post‑marketing portfolios, ensuring patient safety remains at the core of every decision.
Key responsibilities
- Process Individual Case Safety Reports (ICSRs) from clinical trials, post‑marketing sources, devices and combination products in compliance with regulations and client timelines.
- Manage independent SAE/SUSAR activities, including submissions, unblinding and clinical trial reconciliations.
- Prepare database extracts for periodic safety reporting such as PBRER, DSUR and PADER.
- Mentor and train junior team members, contributing to procedure optimisation and departmental development.
Required profile
- Graduate degree in life sciences, biomedical, chemistry, biology, biotechnology, veterinary science or a related healthcare discipline.
- Several years of hands‑on experience in pharmacovigilance case processing.
- Strong organisational, time‑management and multitasking abilities.
- Proactive attitude with a focus on meeting and exceeding targets.
Required skills
- Pharmacovigilance case processing expertise.
- Experience handling SAE/SUSAR submissions and reconciliations.
- Ability to generate safety reporting outputs (PBRER, DSUR, PADER).
What we offer
- Opportunity to work in a global, purpose‑driven environment.
- Collaborative culture that values kindness, flexibility and professional growth.
- Exposure to a wide range of therapeutic areas and regulatory landscapes.
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PrimeVigilance
Belgrade
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