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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Director, Pharmacovigilance (PV) Operations in Cambridge, MA, where you will provide leadership and oversight to Global and Regional PV Operational Teams to ensure adverse event information is processed according to company timelines, performance indicators and quality standards. You will oversee and direct vendor(s) conducting PV operational activities for Takeda. Other PV operational activities includes regional case intake and global processing of Individual Case Safety Reports (ICSRs) monitoring global literature for ICSRs and other post marketing services.

As part of the Patient Safety & Pharmacovigilance (PSPV) team you will report to the Executive Director, PV Operations Oversight, and be responsible for ensuring operational strategy, contract compliance, quality and timeliness of deliverables, and continuous improvement efforts.

How you will contribute:                  

• Ensure standards for collection and processing of ICSRs which include alignment with GDPR requirements.
• Oversee development of global SOPs and policies to ensure compliance with regional PV regulatory requirements and to drive improvements in Takeda global PV processes.
• Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, key performance metrics, and  monitoring of performance and compliance, and training at a global level.
• Liaise with PV Systems team to ensure case processing SOPs and Tools contain guidance to allow for timely and accurate submissions to global health authorities, partners, etc.
• Lead PV relationships with PV vendor(s) and ensure compliance with Service Level Agreements (SLAs) and Pharmacovigilance Agreements (PVAs).
• Direct relationship with and output of vendor(s) in accordance with SLA:
  • Liaises with financial / project management for budget planning
  • Approve invoices and confirm accuracy of spend and bills
  • Lead case processing teams to assess / predict case volumes to ensure staffing planning at vendor
  • Direct planning for ad-hoc case processing related projects e.g. Legal cases
  • Lead and facilitate regular joint operating committee meetings to review / address issues if needed for:
    • Adherence to KPIs, OPIs and SLAs
    • Forecast demand
    • Issue escalations
    • Continuous improvement initiatives
    • Change management
  • Manage / review delivery against MSA terms
  • Monitor global KPIs and SLAs
  • Ensure quality of deliverables across teams
  • Represent voice of vendor to PV function
  • Provide guidance to delivery teams
  • Maintain operating procedures (describing operating rules with vendor)
  • Lead change management and ongoing training
  • Establish and manage vendor oversight procedures

• Partner with PSPV Compliance and QA teams to establish and manage vendor quality agreement procedures.
• Drive preparedness for regulatory authority inspection and internal audits for PV operational activities for Takeda; participate in audits/inspections as Subject Matter Expert (SME) and mentor colleagues/direct reports in audit/inspection preparedness and participation.

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