Overview
In this role you lead the ICSR Management Unit, ensuring delivery of all unit activities and supporting Directors of Projects. You optimize staffing, budgets, and resource deployment to maximize productivity and quality. You mentor line managers and drive process improvements across our pharmacovigilance operations. You will work with cross-functional teams to align with business goals and maintain patient safety as the core focus.
Responsibilities
- Manage the ICSR Management Unit to deliver activities within agreed scope
- Ensure sufficient resources and productivity for project teams
- Set and review productivity targets across ongoing projects
- Allocate resources across ICSR and coordinate with other units
- Oversee Associates Directors and reallocate staff as needed
- Notify Resourcing about additional staffing requirements and approvals
- Propose process improvements and best practices
- Train and mentor ICSR Line Managers and senior staff
- Prepare analyses and reports; review budgets and allocations
- Support Contracts, proposals, HR activities, and quality/operations teams
- Review Critical CAPAs and updates to SOPs and guidelines
- Assist in business development and contract development activities
Key requirements
- Extensive experience in pharmacovigilance case processing (post marketing, clinical, medical devices)
- Senior leadership experience
- Life science background or healthcare qualification
- Strong communication and organizational skills
- Ability to manage budgets and resource allocation
- Experience with HR processes and performance management
- Capability to review and approve CAPAs and SOPs
- Excellent communication
- Strong organization and multitasking
- Effective delegation and management
- MS Office (Advanced)
- Project/resource management
- Data analysis and reporting
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