Job Description
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...