Job Description 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)