Director Pharmacovigilance Business Development, Alliance Management & Vendor Oversight
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.
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- Team Player
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Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.
Director Pharmacovigilance Business Development, Alliance Management & Vendor OversightApply Now
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:
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.
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.
Job ID R0013451