Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical De

Role Overview:

Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader and Line Manages ICSR staff.

Key Responsibilities:

• Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process.
• 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 the supervision of the ICSR Operational Lead.
• Provides 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 the 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.
• Supports other departments, as approved and instructed by the ICSR Operational Lead.
• Operates as the assigned team SME (Subject Matter Expert).
• Supports 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.

Qualifications:

• Life science graduate, pharmacy, nursing, other healthcare-related qualification, or experience in pharmacovigilance.
• Strong previous work experience in pharmacovigilance, with a minimum of 1 year of work experience in a line manager role.