Posted to MedZilla on 5/23/2017

Takeda Pharmaceuticals

US-MA, Director, PV Aggregate Safety Reporting Oversight 1601988-MZ



  • Provides strategic leadership and oversight for the cross-functional management for aggregate safety reports.
  • Ensures aggregate reporting compliance for Global PV at Takeda.
  • Drives vendor requirements and vendor quality management for aggregate safety reporting.


  • Oversee global management and preparation of aggregate safety reports for investigational and marketed products.
  • Ensure Vendor execution and training for preparation of periodic aggregate safety reports.
  • Establish functional specifications for deliverables from the Global safety database for periodic aggregate safety reports.
  • Manage compliance with all regulatory requirements for periodic aggregate safety report deliverables. Ensure vendor compliance with Takeda requirements.
  • Partners cross-functionally internally to define reporting and submission requirements to enable vendor resource planning to deliver all safety reports.
  • Oversee aggregate safety reporting schedules.
  • Drive preparedness for regulatory authority inspection and internal audits for aggregate reporting processes. Serve as the primary functional interface from Pharmacovigilance for subject matter expertise on aggregate safety reporting content.



  • Bachelor s degree required. Advanced degree preferred.
  • Substantial pharmaceutical or health care related industry experience required
  • Must have high level of exposure in preparation and submission of periodic aggregate safety reports in Pharmacovigilance environment
  • Demonstrated experience in people management and well-developed skills in team building, motivating and developing people ideally within an Aggregate reporting function.
  • Expert knowledge of Global regulatory requirements
  • Experience in vendor management for outsourced activities
  • Demonstrate integrity
  • Motivate and empower others
  • Work productively in a high pressure environment
    • Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
    • Project Management abilities
    • Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
    • Able to manage both time and priority constraints and to manage multiple priorities simultaneously
    • Attention to details, computer literacy, knowledge of safety database
    • Take initiative and autonomous action
    • Able to lead teleconferences and meetings
    • Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills


Some travel within Takeda global sites may be required.

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