Associate Director, Pharmacovigilance Business Partner Relations

Company: Takeda Pharmaceutical
Location: Lancaster
Posted on: May 12, 2022

Job Description:

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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 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 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

General
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

TRAVEL 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 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

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EEO Statement
Takeda 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.

Locations
Massachusetts - Virtual

Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Keywords: Takeda Pharmaceutical, Lancaster , Associate Director, Pharmacovigilance Business Partner Relations, Executive , Lancaster, Pennsylvania