Associate Director, Pharmacovigilance Business Partner Relations

Company: Takeda Pharmaceutical
Location: West Orange
Posted on: May 11, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre 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 Business Partner Relations in our Cambridge, MA office.Associate Director of PV Business Partner Relations oversees global strategic initiatives and operational aspects of alliance management. Primary responsibilities include but are not limited to:

• Lead at a high-level, PV alliances/partnerships and associated business activities, including agreements
• Proactively develop and implement process improvement and increased efficiencies for global PV
• Lead and/or significantly contribute to PV due diligence/business development activities - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -ACCOUNTABILITIES: -
  • Develop and implement a scalable process for managing and tracking safety exchange agreements/documents (PVAs / Safety Data Exchange Agreements / SDEA)
  • Review and provide input on -PVAs and associated -Agreements
  • Collaborate with the PV Compliance group to address and resolve compliance issues associated with PVAs
  • Partner with key stakeholders to contribute to the development and maintenance of a global PVA template
  • Support the local Drug Safety Officers DSOs in -Agreement activities as needed
  • Oversee the overall operational aspects of global PV alliances
    • Participate in meetings related to partner alliance and cross-program global operations as required.
    • Identify and work to resolve issues in PV alliances/partnerships.
    • Escalate issues in PV alliances to senior management as appropriate.
      • Oversee vendors handling PVA/alliance management activitiesDue Diligence/Alliance Management
        • Oversee the operational aspects of global PV alliances.
          • Participate in joint company/alliance management meetings as needed
          • Work to resolve issues regarding PV alliances
          • Lead and/or provide strategic contributions to PV due diligence/business development activities
            • Product/company acquisition or licensing
            • Due diligence activities for global PV
            • Due diligence process documentsGeneral
              • Escalate issues/problems to senior management as needed
                • Any other tasks assigned by manager to assist in departmental activitiesEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -
                  • Bachelor's required. - Post-graduate degree or equivalent (Masters Degree/MBA) preferred
                  • 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
                  • Able to lead teleconferences and meetings
                  • Project management training and experience
                  • Proven ability to create and implement operational efficiencies
                  • Excellent oral and written communication skills
                  • Strong relationship management skills
                  • Expertise in clinical research and product safety activities in the pharmaceutical industry
                  • Ability to handle confidential information appropriately
                  • Preferred experience in vendor management
                  • Minimum 8 years of experience in pharmaceutical/biotech industry or a minimum 3 years of experience in pharmacovigilance, clinical research, or alliance management role with advanced degreeTRAVEL REQUIREMENTS:
                    • Estimated up to 5 travel times per year, including possible international travel.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 ProgramsEmpowering Our People to ShineLearn more at -.Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit -No Phone Calls or Recruiters Please.#LI-MT1EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, West Orange , Associate Director, Pharmacovigilance Business Partner Relations, Executive , West Orange, New Jersey