Job Overview
- Assures and exerts activities leading to effective cooperation with clients in the area of ICSR Management
- Contributes to achieving company´s goals and objectives
- Works under supervision of more experienced colleague
- Providing support to other activities undertaken by the project team on behalf of the client and the company
- Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
- 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)
- Product Quality Complaint handling and interaction with Quality Assurance
- Medical Information interaction
- Database Outputs and Reports (including data for monthly reporting to clients)
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