Posted to MedZilla on 1/19/2020

Takeda Pharmaceuticals

US-MA, Associate Director Pharmacovigilance Strategy and Business Planning R0013980-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 an Associate Director Pharmacovigilance Strategy and Business Planning in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director Pharmacovigilance Strategy and Business Planning working on the PV Services team, you will be empowered to Create and Innovate. A typical day will include:


This position is responsible for helping to further the strategic advancement of Pharmacovigilance in support of PV s mission to ensure patient safety. Primary responsibilities include but are not limited to:

  • Leading key initiatives that have cross-functional impact and that are critical to PV s business objectives and/or Takeda s global business objectives. This includes integration activities related to acquisitions, mergers and divestments.
  • Provides expert project/program management and leadership skills to ensure internal, cross-functional, cross-divisional project plans are in place for PV related initiatives. This includes providing strategic direction and translating the cross-divisional, integrated PV strategy into an executable plan using innovative approaches to ensure rapid and effective decision making
  • Work directly with the Global Patient Safety Evaluation (GPSE or PV) Head, Chief of Staff (COS), GPSE Leadership Team, and outside departments to support the strategic direction of GPSE by leading high-impact, high-priority projects and overseeing department-wide initiatives.
  • Support functional resourcing oversight using financial forecasting and headcount management techniques to drive operational excellence.


  • Utilize project and program management expertise to drive project teams to achieve clarity on issues and focus on effective contingencies; interface with management and influence decision-making, monitor progress, gaps, risk management to ensure progress and business continuity
  • Lead or support integration projects for M&As/divestments, which may include representing GPSE on cross-functional integration or divestment teams. Directly manage and/or liaise with appropriate SMEs on all aspects of the GPSE integration/divestment, including project plans & timelines, budget, personnel transitions, safety systems migrations, etc.
  • Enable GPSE to be a successful partner in due diligence activities by creating a Due Diligence Center of Excellence; author and maintain due diligence SOPs, tools, templates, and other related resources.
  • Liaise with other GPSE functions and Business Development to support due diligence reviews of target companies Pharmacovigilance System, infrastructure, and organization.
  • Proactively identify and drive project and resource priorities that align with global business objectives. Work closely with stakeholders to balance operational execution with GPSE strategy
  • Support transformational projects/initiatives and change-management activities.
  • Identify and execute opportunities for infrastructure enhancements and efficiencies, including process improvement.
  • Develop and implement tools and templates to enable consistency and transparency across GPSE projects.
  • Liaise with Takeda s Vaccine Business Unit to prepare for GPSE support of post-marketing vaccine activities.
  • Manage and track GPSE budget and FTE resources along with GPSE Chief of Staff, including yearly mid-range planning efforts with Global Finance, comprehensive FTE capacity planning, monthly headcount reconciliation, and GPSE travel oversight.
  • Support GPSE outsourcing initiatives and vendor engagement, including strategic future-state planning. Work with stakeholders to identify and support implementation of opportunities for efficiency gains.
  • Contribute to GPSE goal and KPI development, initiative tracking and prioritization, and team engagement activities.
  • Represent pharmacovigilance department in cross-functional teams and/or meetings at a regional and global level as required, alongside the commensurate communication skills required.


  • Bachelors required. Post-graduate degree or equivalent (Masters Degree/MBA) preferred
  • Experience in program and/or project management, preferably in the Pharmaceutical or Biotech industry in clinical development, regulatory affairs, pharmacovigilance, or related function.
  • Strong ability to proactively identify areas for process improvement and lead infrastructure-related projects efficiently and within given time constraints
  • An understanding of and experience in the drug development process, including post-marketing and life-cycle management, with a focus on drug safety/pharmacovigilance
  • Experience in and knowledge of due diligence for company acquisitions/divestments and/or licensing partnerships
  • Demonstrated ability and experience leading high performing teams internally and cross functionally in a global highly matrixed and collaborative environment
  • Ability to proactively identify and anticipate project risks, including those associated with non-adherence to the regulations, and a keen understanding of when to escalate issues quickly and efficiently
  • Experience in Alliance Management both with external business partners/vendors, and with internal key stakeholders and colleagues. Ability to interact effectively with staff of multiple disciplines both within and outside the company both nationally and internationally
  • Strong understanding and knowledge of the business areas both internally within the organization and touch points externally
  • Excellent time management skills
  • Self starter and strategic thinker
  • Able to lead teleconferences and meetings
  • Ability to drive change and manage complex situations, particularly with multinational matrix teams
  • Proven ability to create and implement operational efficiencies
  • Excellent oral and written communication skills
  • Strong relationship management skills
  • Ability to handle confidential information appropriately


  • Estimated 5-10 travel times per year, including possible international travel.


  • 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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