Manager, PV Strategic Partner Management

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.   

Job Summary:

Manage Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Contribute as a key DSI contact for PV service providers to address, escalate issues requiring attention or resolution, and proactively drive operational excellence and continuous improvement. Manage DSI's Strategic PV Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI contracts that are PV relevant and AE reporting language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received from CSPV vendors.

Responsibilities:

Strategic Partner Management:

• Manage Local/Global PV service providers responsible for Call Center, individual safety case processing, and aggregate reporting.

• Establish and maintain collaborative relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.

• Facilitate operational meetings with CROs, License Partners, and PV vendors.

• Assist with PV oversight of the DSI Call Center.

• Manage oversight of ICSR processing activities including, Safety Information submission to Health Authorities and License Partners, Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other suppliers.

• Ensure adequate training of resources to enable quality of deliverables. Manage quality, efficiency, and resources for PV service providers/vendors.

• Measure and monitor performance of vendors against service level and KPIs.

• Manage the development of governance, business continuity, quality, and vendor monitoring plans. Maintain oversight for capability development of service provider and resources.

• Plan, allocate, and utilize resources and prioritize assignments. Contribute to management and escalation of issues for resolution.

• Coordinate vendor assessments and make recommendations on vendor partners. Manage the coordination of PV participation in due diligence for acquisitions and divestments.

• Assist with negotiation and transfer of PV Business in case of Product Divestment. Collaborate with DSI audit groups to ensure comprehensive auditing of Business Partners as required to assure compliance with PV agreements.

• Participate in audit and inspection readiness activities. Provide input for re mediating PV system deficiencies cited in audit/inspections. Manage the implementation of effective corrective and preventative action

PV Agreements and Contracts:

• Manages PVAs/SDEAs and maintains oversight of PV relevant contracts. Contribute to overseeing and setting standards for PV contract management. Review contributes to revision of DSI contracts under negotiation (e.g. development, license, distribution agreements)Manage, negotiate, revise document collaborative license partner safety agreements with counterparts from (license) partner companies. Participate in the development and maintenance of a PVA repository. Contribute to the development of standard processes and contract templates in cooperation with Legal Department and PV functions. Assist in the development of standards for information exchange with partners in cooperation with PV functions. Initiate the implementation of obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence

PV Regulatory Intelligence:

• Contribute to the management of PV Regulatory Intelligence and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PV regulatory intelligence reports received from CSPV vendors.

• Management Strategy and Goals: Assist CSPV Leadership in developing PV goals, continued compliance, and strategy for process improvement initiatives.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education:

• Bachelor's Degree Nursing, Pharmacy, Life Sciences, Health Care or related field required

• Master's Degree Life Sciences preferred

• PharmD Life Sciences preferred

Experience:

• Minimum of 3 years of management experience in PV preferred

• Minimum of 5 years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products; required

• 4 or More Years Knowledge of Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) required

• 4 or More Years Knowledge of FDA regulations, clinical and safety databases; preferred

• 4 or More Years Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP), PharmD, RN, or master’s degree in life sciences preferred

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range: