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Job Description:
The Senior Manager, Pharmacovigilance (PV) Document Management Oversight, is responsible for the development, implementation, and maintenance of robust procedures for the planning, preparation and submission of high-quality aggregate safety reports, in compliance with requisite global and local regulations and requirements.
Primary duties and responsibilities of the role include the following
- Provides leadership to regional aggregate reporting team including training, mentoring, development, and appraisals
- Assists in management of departmental budgets
- Ensures aggregate reporting processes and procedures are complete and compliant with current regulations globally
- Interacts and communicates effectively internally and cross-functionally in a highly matrix workplace.
- Responsible for the implementation and management of effective structure, procedures, and tools to ensure aggregate report and other functional deliverables are completed with high quality
- Responsible for global leadership and strategic oversight of aggregate safety reports for investigational and marketed products
- Collaborates with Global Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs, Finance, Safety Statistics, etc.) contributing to aggregate safety reports
- Manages distribution of assignments and prioritization of tasks within the Pharmacovigilance operations aggregate reporting team
- Manages resource planning and ensures adequate support from internal team and vendor team to deliver all scheduled safety reports.
- Manages commitments with license partners to ensure both