Pharmacovigilance (PV) Associate
PrimeVigilance · Belgrade
Description du poste
About the role
PrimeVigilance is looking for a motivated PV Associate to join its global pharmacovigilance team. You will support the processing and management of safety data, ensuring compliance with regulations and client requirements while contributing to patient safety.
Key responsibilities
- Process Individual Case Safety Reports (ICSRs) from all sources in line with regulations and PrimeVigilance SOPs.
- Perform follow‑up activities, including SAE/SUSAR management, unblinding, clinical trial reconciliation, and protocol review.
- Conduct clinical and partner data reconciliations and ensure personal data protection.
- Handle product quality complaints and interact with Quality Assurance and Medical Information teams.
- Apply MedDRA and WHO coding to safety data.
- Support PV processes for both PrimeVigilance and its clients.
- Act as Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS) for designated languages/countries as required.
Required profile
- Life‑science degree (pharmacy, nursing, or related) or relevant pharmacovigilance experience.
- 0‑1 year experience in pharmacovigilance (desirable but not mandatory).
- Strong organisational skills, attention to detail and ability to multitask.
- Effective time and issue management capabilities.
- Advanced English (spoken and written).
- Proficiency with MS Office applications.
Required skills
- MedDRA coding
- WHO coding
- MS Office
What we offer
- A culture built on kindness, flexibility, growth and belonging.
- Global reach with opportunities to develop expertise in drug safety.
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PrimeVigilance
Belgrade
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