Job Overview
- Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader and Line Manages ICSR staff
- Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process
- Assures and exerts of 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 ICSR Operational Lead
- Role and Responsibilities
- Providing support to other activities undertaken by the project team on behalf of the client and the company
- Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency)
- Proposes process changes to ICSR Operational Lead
- Manages ICSR deviations with ICSR Operational Lead support
- Reviews trackers and timesheet data and ensures accuracy
- Is involved in ICSR processing and 2nd QC of cases
- Support other departments, as approved and instructed by ICSR Operational Lead
- Operates as the assigned team SME
- Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager
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