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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 meet aggregate re