Director, Pharmacovigilance Alliance Management
We Aspire to Cure Cancer! Millennium is a leading biopharmaceutical company focused on oncology that combines the agility, ideals and camaraderie of a start-up with the resources of Japan's largest pharmaceutical company. The result is a creative, entrepreneurial environment where quality science and making a difference in patients' lives are the priorities. Here, employees who share a drive and commitment to innovation for the benefit of oncology patients find their ideas, experience and contributions are valued and rewarded. Millennium offers great benefits, a friendly and respectful atmosphere, and a culture that promotes flexibility between work and life and encourages employees to give back to their community.
Responsible for establishing PV global strategy and leading PV business development activities and initiatives, including:
* Overseeing the development of and life-cycle management of Safety Data Exchange Agreements (SDEAs) and PV Agreements (PVAs)
* Leading and managing PV due diligence activities
* Working effectively cross-functionally to ensure global alignment from key stakeholders
* Working towards and maintaining effective and efficient working relationships with Alliance Partners SDEAs and PVAs
* Develop and implement a scalable process for managing and tracking all existing and future SDEAs and PVAs from Takeda and legacy Companies (e.g., Nycomed and Millennium).
* Oversee the creation and management of a global SDEA/PVA template.
* Communicate with HQ sites in Europe, Asia, and Americas regularly to ensure appropriate dissemination of information regarding responsibilities outlined in SDEAs and PVAs.
* Oversee the development and maintenance of and adherence to SDEAs, PVAs, Side Letters, Safety Exchange documents, as well as Safety Team Charters. o to be developed in consult with Global Medical Safety and Global PV operations
* Collaborate with the LOC managers and the DSOs in Service Level Agreement activities as needed.
* Partner with the Global PV Standards, Compliance and Training Lead and Global PV Alliance Management Team (e.g., set agenda topics and schedule, facilitate discussions, distribute minutes, etc.).
* In collaboration with leaders in Global Standards, Compliance and Training Lead, and leader of global PV Standards, develop and implement compliant PV systems.
* 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. Due Diligence/Alliance Management
* Participate in business development activities product/company acquisition or licensing.
* Lead and manage due diligence activities for global PV.
* Develop and maintain due diligence process document.
* Participate in the asset transition team.
* Manage the alliance/external relationships for global PV.
* Participate in joint steering teams with alliance partners as needed.
* 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
To apply for this position, please CLICK HERE