Director, PV Strategic Partner Management

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Job description

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.

Summary

Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains 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. Oversees 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. Serves as the key DSI contact for PV service providers to address, escalate issues requiring attention or resolution, and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received from CSPV vendors. Collaborates with cross functional teams to assess impact of regulatory changes for CSPV and develop strategies to maintain compliance with global PV regulations for individual case safety reporting, periodic reporting and risk management. Develops and implements strategic initiatives for global process harmonization and continuous improvement across Strategic Partner Management responsibilities.

Responsibilities

PV Agreements and Contracts:

Leads PVA/SDEA Management and maintains oversight of PV relevant contracts. Oversee and set standards for PV contract management. Review contribute to revision of DSI contracts (e.g. development, license, distribution agreements)Manage, negotiate, and revise collaborative license partner safety agreements with counterparts from (license) partner companies. Responsible for development and maintenance of a PVA repository Lead development of contract templates in cooperation with Legal Department and PV functions. Drive 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. Support business functions in determining PV relevance for vendor contracts. Ensures compliance with global PV regulations and the contractual obligations that govern the exchange of safety data between partners in relation to marketed and clinical products.

Strategic Partner Management:

Oversees 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. Provide PV oversight of the DSI Call Center. Provide 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. Develop governance, business continuity, quality, and vendor monitoring plans. Maintain oversight for capability development of service provider and resources. Manage and escalate issues for resolution. Coordinate vendor assessments and make recommendations on vendor partners. Coordinate PV participation in due diligence for acquisitions and divestments. Negotiate and organize 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 remediating PV system deficiencies cited in audit/inspections. Implement effective corrective and preventative action

PV Regulatory Intelligence:

Oversees the management of PV Regulatory Intelligence including gathering, monitoring, analyzing and disseminating information across CSPV stakeholders for impact assessment: Monitors and tracks regulatory trends, legislative changes, and guidelines issued by global regulatory agencies (FDA, EMA, MHRA, etc.) related to CSPV. Participates in the review and management of monthly, quarterly, and ad hoc PV regulatory intelligence reports received from CSPV vendors. Facilities CSPV requests for regulatory intel with the vendor. Maintains up to date knowledge of local, regional, and international PV regulations. Act as a subject matter expert in regulatory intel for PV and provides strategic advice to stakeholders. Collaborates with cross-functional teams to assess the impact of regulatory changes for CSPV. Maintain records of regulatory intelligence activities and impact assessments to ensure documentation is available for audits and inspections

Management Strategy and Goals:

Assist in developing PV goals, continued compliance, and strategy for process improvement initiatives as a member of PV Operations leadership.

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

Education Qualifications (from an accredited college or university)

- Bachelor's Degree Bachelor's degree in nursing, pharmacy, life sciences, health care or related field is required
- Master's Degree preferred
- PharmD preferred

Experience Qualifications

- A minimum of 5 years of professional management experience in PV required
- 10+ years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products required
- Knowledge of Adverse Event and drug coding conventions (MedDRA, WHO-DD)
- Knowledge of FDA and global PV regulations, clinical and safety databases
- Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP)

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.

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