Posted to MedZilla on 3/25/2017

Takeda Pharmaceuticals

US-MA, Director, PV Post Marketing Services 1602013-MZ



  • The Director Post Marketing PV Services is responsible for oversight of PV operational activities for Takeda marketed products. This individuals role provides a level of expertise, aligned with the principles and standard practices for operational activities related to Post Marketing programs.
  • Responsible for PV vendor oversight and operational strategy, contract compliance, quality and timeliness of deliverables, and continuous improvement related to outsourced post marketing PV activities.
  • Partners with key stakeholders within and outside PV to ensure continuous harmonised operations of global PV activities and to maintain high standards for functioning in an integrated environment.
  • Serve as the process owner for the PSP/MR programme process within GPV including representation as the single point of contact and link between GPV and commercial (including the LOCs)




  • Oversee processes that link Market Research, Patient Support Programs, IISR studies and post marketing observational programs to post marketing PV operations activities
  • Define the standards and requirements per global regulations for reporting of post marketing safety reports. This includes process for follow-up with reporter/HCP to collect relevant information to complete case assessment per regulatory requirements
  • Provide oversight of vendors responsible for post marketing PV activities and be responsible for tracking quality of work per Quality Management Plan
  • Oversee the vendor performing the review of post marketing non-interventional safety sections of study data management plans, agreements and protocols for PV operations
  • Establish guidance for the LOC and DSOs for all safety responsibilities associated with marketed products
  • Oversee communication with alliance partners and CROs regarding the evaluation and processing of ICSRs
  • Provide oversight for global literature search processes and vendors for investigational and post marketed products
  • Ensure ICSR timeline compliance by monitoring metrics reports from case processing vendor(s). This includes and case exchange with applicable parties per safety data exchange agreements
  • Oversee processes with quality assurance in the collection, exchange, review, identification, and reconciliation of product complaints for potential adverse events
  • In conjunction with the GSLs (and where appropriate other groups within GPV e.g. LOCs) and commercial business units, oversee compliance with PV requirements at initiation, execution, and close out of MR/PSPs
  • Oversee management of the PV vendor executing registration, tracking, reconciliation and close-out documentation for MR/PSP managing part of the process
  • Ensure that metrics are identified, documented, and reported to GSCT and QA, and other stakeholders for MR/PSPs.
  • Partner with QA to ensure that the quality plan is followed for MR/PSPs and appropriate metrics reported to the Head of QA, Head of GPV and the commercial business units
  • Proactively partner with GSLs, DSO, commercial teams and other MR/PSP stakeholders to forecast and manage annual plan for MR/PSP programs.
  • Based on annual MR/PSP forecast, plan Operations capacity to support MR/PSP plan
  • Oversee the Global PSP/MR tracking system and ensure the tracking of MR/PSPs and retrieval of outputs for regulatory purposes

Some travel to global Takeda sites may be required.

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