Senior Pharmacovigilance Associate
PrimeVigilance · Belgrade
Description du poste
About the role
PrimeVigilance is seeking a Senior Pharmacovigilance Associate to join its global safety team. You will manage Individual Case Safety Reports (ICSRs) and support a range of pharmacovigilance activities, ensuring compliance with regulations and client requirements.
Key responsibilities
- Process ICSR data from all sources in line with regulations and internal SOPs.
- Conduct follow‑up activities, including SAE/SUSAR management, unblinding, and clinical trial reconciliation.
- Perform data reconciliation with clinical partners and manage personal data protection.
- Handle product quality complaints and interact with Quality Assurance.
- Provide medical information support and apply MedDRA and WHO coding standards.
- Generate database outputs, monthly reports, and other client deliverables.
- Support workflow, resource management, and broader PV processes.
- Act as Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS) when required.
Required profile
- Life‑science degree (pharmacy, nursing, or related) or equivalent pharmacovigilance experience.
- Minimum 1 year of PV experience.
- Strong organisational skills, attention to detail and ability to multitask.
- Effective time and issue management capabilities.
- Advanced spoken and written English.
- Proficiency with MS Office applications.
Required skills
- MedDRA coding
- WHO coding
- Advanced MS Office proficiency
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PrimeVigilance
Belgrade
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