ICSR Team Leader / Pharmacovigilance Lead

Role and Responsibilities

• Lead the team responsible for ICSR management for a selected project or group of projects as Team Leader.
• Ensure adequate distribution of tasks for assigned projects and teams, and oversee the workflow process.
• Assure and exert activities leading to effective cooperation with clients in the area of ICSR Management.
• Provide support to other activities undertaken by the project team on behalf of the client and the company.
• Line manage assigned ICSR staff.
• Create and maintain project-specific KPIs for contracted ICSR activities, including optimizing procedures, trainings, and other actions to increase ICSR team efficiency.
• Propose process changes to the ICSR Operational Lead.
• Manage ICSR deviations with ICSR Operational Lead support.
• Review trackers and timesheet data to ensure accuracy.
• Be involved in ICSR processing and 2nd QC (Quality Control) of cases.
• Operate as the assigned team SME (Subject Matter Expert) and support other SMEs.

Requirements

• Life science graduate, pharmacy, nursing, or other healthcare-related qualification or experience in pharmacovigilance.
• Extensive experience in pharmacovigilance, with demonstrated work experience in a line manager role.