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Director Pharmacovigilance Business Development, Alliance Management & Vendor Oversight

Cambridge, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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Director Pharmacovigilance Business Development, Alliance Management & Vendor Oversight

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Job ID R0013451 Date posted 11/08/2019 Location Cambridge, Massachusetts

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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 Director Pharmacovigilance Business Development, Alliance Management and Vendor Oversight in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director Pharmacovigilance Business Development, Alliance Management and Vendor Oversight working on the PV Services team, you will be empowered to Create and Strategize. A typical day will include: 

OBJECTIVE: 

Responsible for establishing GPSE global strategy for Business Partner Relations and leading PV business development operational activities and initiatives, including:

  • Overseeing the development of and life-cycle management of PV Agreements (PVAs)
  • Working effectively cross-functionally to ensure global alignment from key stakeholders
  • Working toward and maintaining effective and efficient working relationships with PV Business Partners
  • Leading and managing PV-specific due diligence activities as assigned
  • Creation and execution of GPSE vendor oversight strategy
  • Through the application of various vendor oversight tools, systems and techniques deliver business value in line with agreed upon PV goals. 
  • Provide supplier governance support for key partnerships

ACCOUNTABILITIES:  (Describe the primary duties and responsibilities of the job.  Approximately 5 – 10 bulleted task statements should be identified).

  • Lead the Global Pharmacovigilance Business Partner Relations group and the vendor oversight team
  • Develop and implement a scalable global infrastructure for managing and tracking all existing and future PVAs from Takeda and legacy Companies from M&A activity).
  • Oversee the creation and management of global PVA processes and templates in line with current industry standards and regulations.
  • Communicate with HQ sites in Europe, Asia, and Americas regularly to ensure appropriate dissemination of information regarding PVA responsibilities and commitments.
  • Oversee the development and maintenance of and adherence to PVAs, Memorandum of Understanding, Termination Letters and related documents.
    • developed in consult with Global Medical Safety and Global PV Operations
  • Manage PV compliance-related communications with Takeda Business Partners.
  • Collaborate with the LOC managers and the DSOs in PVA activities as needed.
  • Oversee the operational aspects of Global PV alliances. Identify and work to resolve issues in PV alliances/partnerships. Support HQ sites and LOCs in PV alliance management issues as needed.
  • Create and manage the GPSE vendor oversight strategy to support the business owners in executing vendor oversight plans
  • Partner with GPSE vendor leads to ensure inspection readiness activities are achieved
  • Partner with Procurement on GPSE vendor sourcing initiatives to drive value.
  • Ensure GPSE stays current with industry leading vendor oversight practices
  • Participate in business development activities product/company acquisition or licensing, including review of License Agreements.
  • Manage due diligence activities for GPSE.
  • Develop and maintain due diligence process document.
  • Manage the alliance/external relationships for GPSE.
  • Participate in PV partner operations management teams with alliance partners as needed.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Professional Profile – Education and experience

  • Bachelors required.  Advanced degree preferred.
  • Minimum 10 years pharmaceutical or health care related industry experience required. 
  • Minimum 5 years in pharmaceutical experience with product development and alliance work
  • Strong PV knowledge including experience working in alliance partnerships
  • Experience in but not limited to developing PV safety agreements, safety team charters, service level experience
  • Experience in and knowledge of due diligence for company acquisitions and/or licensing partnerships
  • Product development including clinical safety experience
  • Ability to interact effectively with staff of multiple disciplines both within and outside the company both nationally and internationally
  • 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 risks associated with non-adherence to the regulations
  • 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
  • Formal management training/experience and demonstrated management skills preferred.

TRAVEL REQUIREMENTS:

Periodic international travel to Takeda global sites may be required.

WHAT TAKEDA CAN OFFER YOU:

  • 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

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0013451

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