Associate Director, Pharmacovigilance Business Partner Relations
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Associate Director, Pharmacovigilance Business Partner RelationsApply Now
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 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
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 activities
Due 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 documents
Escalate issues/problems to senior management as needed
Any other tasks assigned by manager to assist in departmental activities
EDUCATION, 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 degree
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
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.
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 http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.
Job ID R0017009