Full-Time Safety Reporting Manager, Team Leader

Manages and mentors the safety reporting staff in the ICSR Management Unit

Ensures adequate distribution of tasks for assigned safety reporting staff and oversees the workflow process

Operates as the link between Regulatory Intelligence Department and ICSR Management Unit to ensure accurate guidelines are followed and optimal processes are in place

1. ROLE AND RESPONSIBILITIES
2. Providing support to activities related to safety reporting undertaken by the project team on behalf of the client and the company
3. Reporting Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
4. SAE/SUSAR Reporting Management
5. Workflow & resource management
6. Line Management tasks (periodic appraisals, performing vacation approval, ensuring adequate cover is in place to meet operational requirements for existing and new contracts)
7. Mentoring and training of new and more junior employees within the department

Team Leader responsibilities:

• Leads the team responsible for safety reporting
• Leadership and expert advice in the area of safety reporting
• Line management of the assigned team and subordinated colleagues
• Training and development of skills

Life Science Degree

Demonstrated safety reporting experience

Strong line management experience

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