Senior Pharmacovigilance Associate
PrimeVigilance · Belgrade
Job description
About the role
PrimeVigilance is seeking a Senior Pharmacovigilance Associate to join its global safety team. You will work on processing and managing Individual Case Safety Reports (ICSRs) for pharmaceutical clients, ensuring compliance with regulations and delivering actionable safety insights.
Key responsibilities
- Process ICSR data from all sources in line with regulatory requirements, PrimeVigilance SOPs and client timelines.
- Conduct follow‑up activities, including SAE/SUSAR management, unblinding, clinical trial reconciliation and safety plan reviews.
- Perform data coding using MedDRA and WHO dictionaries and generate database outputs and monthly reports.
- Handle product quality complaints, interact with Quality Assurance and Medical Information teams.
- Support data protection, personal data handling and workflow/resource management.
- Act as Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS) for designated language/country when required.
Required profile
- Life‑science degree (pharmacy, nursing or related) or equivalent pharmacovigilance experience.
- Minimum 1 year of experience in pharmacovigilance.
- Strong organisational skills, attention to detail and ability to multitask.
- Advanced English (spoken and written).
Required skills
- MedDRA coding
- WHO coding
- Proficiency with MS Office
What we offer
- Opportunity to work in a global, purpose‑driven environment.
- Culture built on kindness, flexibility and professional growth.
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Published 1 week ago
Expires 1 month from now
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PrimeVigilance
Belgrade
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