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Job Description:

The Associate Director, 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.

Accountabilities include

• 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 setting.
• 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 reporting requirements

📌 Associate Director, PV Document Management Oversight (Bengaluru)
🏢 Takeda
📍 Bengaluru