Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.
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.
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.
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 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 Agreements and Contracts: Manages PVAs/SDEAs and maintains 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 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
PV Regulatory Intelligence:
- Oversees 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.
Education and Experience:
Bachelor's degree in nursing, pharmacy, life sciences, health care or related field;
Minimum of three (3) years of management experience in PV;
Minimum of seven (7) years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products;
Knowledge of AE and drug coding conventions (MedDRA, WHO-DD).
Knowledge of FDA regulations, clinical and safety databases,
Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP)
PharmD, RN, or Master's degree in life sciences preferred
- Ensures high quality work is completed throughout the function and that internal and external expectations and timelines are met.
- Develops functional strategic plans, provides guidance on priorities within the function and leads implementation.
- Expertly identifies issues independently, thoroughly understands cause of issues, recognizes functional impact, develops and implements solutions.
- Expert scientific knowledge is used to provide leadership and to serve as subject matter expert throughout the function.
- Routinely interfaces, collaborates, and negotiates with project and functional leaders to drive results and resolve complex issues.
- Assists in driving timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional needs.
- Applies PV and contractual knowledge to influence strategy and promote efficiency and compliance for assigned projects within the team and externally.
- Drives CAPA implementation with vendors and partners