Associate Director, PV Strategic Partner Management

Job Title: Associate Director, PV Strategic Partner Management Job Requisition ID: 1455 Posting Start Date: 5/4/26 Job Summary 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, elevate 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). 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 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: 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 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 Develop 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 Manage and elevate 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 Manage PVAs/SDEAs and maintain oversight of PV relevant contracts Oversee and set standards for PV contract management Review & contribute 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 Responsible for development and maintenance of a PVA repository Lead development of standard processes and 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 implementation of obligations deriving from these contracts Organize and conduct periodic review of contract quality and adherence Oversee the Management of PV Regulatory Intelligence and dissemination across CSPV stakeholders for impact assessment Participate in the review and management of monthly, quarterly, and ad hoc PV regulatory intelligence reports received from CSPV vendors Assist CSPV Leadership in developing PV goals, continued compliance, and strategy for process improvement initiatives Qualifications Education Qualifications Bachelor's Degree in nursing, pharmacy, life sciences, health care or related field; required. A higher-level degree such as a PharmD or Master's Degree in life sciences preferred Experience Qualifications Must have a minimum of 4 or more years of professional pharmaceutical industry experience in PV management Proven knowledge of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products Must have strong knowledge of Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) Knowledge of FDA regulations, clinical and safety databases; preferred Experience with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) 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:

USD$153,600.00 - USD$230,400.00

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