Senior Pharmacovigilance Associate

PrimeVigilance • Kraków, Lesser Poland Voivodeship • Posted June 12, 2026

About the Role

Job Description

 

  • Performing activities in the scope of ICSR management unit within agreed extent and timeframe:
    • Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
    • Performing ICSR follow up
    • SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
    • Reconciliation (clinical, partners)
    • Personal data protection
    • Product Quality Complaint handling and interaction with Quality Assurance
    • Medical Information interaction
    • MedDRA and WHO coding
    • Database Outputs and Reports (including data for monthly reporting to clients)
    • Workflow & resource management
  • Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
  • More senior c...