Senior Pharmacovigilance Associate

• 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...

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