Posted to MedZilla on 11/11/2019

Takeda Pharmaceuticals

US-MA, Sr. Manager PV Processes R0013332-MZ


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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Sr. Manager PV Processes in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Sr. Manager PV Processes working on the PV Services team, you will be empowered to Create and Strategize. A typical day will include:


  • Oversee operations performed by the PV BPO vendor including contract compliance, quality and timeliness of deliverables.
  • Serve as a primary liaison and point of contact for vendor operations and vendor oversight, including vendors performing case management, case intake (i.e., Call Centers), scientific literature review, etc.
  • Serve as the primary liaison and point of contact for vendor operations including the PV BPO vendor and/or vendors performing case management, case intake, literature review; call centers
  • Provide Subject Matter expertise (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, legal case processing, vendor oversight, etc.


  • Provide leadership and oversight on case management for the Global PV Operations Team to ensure adverse event information is processed according to company timelines and quality standards
  • Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to global Health Authorities, alliance partners, local operating companies (LOCs) including SUSAR and SAE communication to ECs and investigators as applicable
  • In partnership with the Global Standards and Compliance team, direct and manage communication with alliance partners, LOCs and CROs regarding the evaluation and processing of ICSRs
  • In partnership with the Global Standards and Compliance team, lead and direct the review and approval of alliance partner safety data exchange agreements for the inclusion of appropriate safety reporting requirements
  • Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, metrics, and monitoring of performance and compliance, and training at a global level
  • Oversee and direct reconciliation processes for case exchange with LOCs and alliance partners
  • Lead PV relationship with PV BPO vendor and/or vendors performing case management to ensure compliance with SLAs
  • Support LOCs in PV tasks responding to queries and requests regarding case handling
  • Interface with commercial quality for product complaints; assist in obtaining follow-up when necessary for adverse events, product quality complaints or other safely information
  • Direct relationship with and output of BPO partner(s) in accordance with SLA
    • Liaises with financial / project management for budget planning
    • Approve actual invoices and confirm accuracy of spend and bills
    • Coordinate clinical and project management case processing teams to assess / predict case volumes to ensure staffing planning at vendor
    • Lead planning for ad-hoc case processing related projects e.g. Legal cases or AE/SAEs generated through marketing surveys
    • Lead and facilitate regular joint operating committee meetings to review / address issues if needed for:
      • Adherence to KPIs 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 manual (describing operating rules with vendor)
    • Lead change management and ongoing training
  • Establish and manage vendor oversight procedures
  • Partner with QA to establish and manage BPO vendor quality agreement procedures include vendors performing case management/intake activities or literature review and surveillance


  • Bachelor s required. Advanced degree in scientific/medical field preferred.
  • Good cross cultural understanding and experience
  • Experience in people management and well developed skills in teambuilding, motivating and developing people.
  • Demonstrated skills in negotiation and consensus decision making
  • Critical thinking and analytical skills and ability to make key decisions
  • Demonstrated effectiveness in external partner relationship management
  • Understanding of medical/scientific terminology
  • Good knowledge of PV regulations for the global pre-and post-market, i.e. FDA, EMA, ICH GVP
  • Experience with safety databases, including MedDRA and WHO Drug
  • Excellent written/oral communication skills
  • Accuracy and attention to detail
  • Flexible mindset
  • Team worker with collaborative approach
  • Ability to prioritize under pressure
  • Well-developed organizational skills


RN or Pharmacist preferred


Some travel to global Takeda sites may be required.


  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

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Cambridge, MA

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Full time

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