Manager, PV Partner Management (PVA), CSPV

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.
SummaryManage DSI's Strategic Partnerships and contracts including vendor outsourcing agreements, partner contracts PV Agreements (PVAs) [Safety Data Exchange Agreements (SDEAs)]. Management of relationships with Contract Partners and Pharmacovigilance Information Exchange in Contractual Arrangements to ensure good Pharmacovigilance practice and regulatory compliance in such arrangements. Oversees the service provider and offshore unit responsible for call center, case management, medical writing and risk management support for DSI products, both investigational and marketed, to ensure accurate assessment and timely reporting of safety information. Serves as the key DSI contact for the service provider and offshore unit to address and escalate issue requiring attention or resolution. Manages service provider and offshore unit to proactively drive operational excellence and continuous improvement. Measures and monitors performance of vendor and offshore unit against defined service levels and/or metrics to ensure timeliness, efficiency and quality of deliverables. Ensures service provider's and offshore unit's inspection readiness for inspections and audits of the Pharmacovigilance system. Maintains oversight for capability development of service provider and offshore unit resources.

Responsibilities

• Strategic Partner Management: Acts as subject matter expert in active contracts DSI has with strategic partners and vendor.
  • Review & contribute to revision of DSI contracts under negotiation (e.g. development, license, distribution agreements)
  • Manage, negotiate, revise & document license partner safety agreements with counterparts from (license) partner companies
  • Responsible for development and maintenance of a License agreement database
  • Contribute to development of standard processes and contract templates in cooperation with Legal Department and PV functions
  • Contribute to 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
  • Collaborate with DSI audit groups to ensure comprehensive auditing of License Partners as required to assure compliance with PV agreement
  • Manage CRO contracts including issue handling
  • Coordinate PV participation in due diligences in acquisitions and divestment
  • Negotiate and organize Transfer of Pharmacovigilance Business in case of Product Divestment
  • Coordinate vendor assessments and make recommendations on vendor partners
  • Direct and guide service provider and/or offshore unit:
  • Provide oversight for call center
  • Provide oversight for case management activities including, but not limited to, Safety information submission to health authorities; global notification of safety information to Business Partners; Reconciliation with Patient Support Programs and Market Research vendors, Business Partners, Global Quality Supply Chain, Medical Information and other suppliers
  • Plan, allocate and utilize resources and prioritize assignments
  • Manage quality, efficiency and resources for service provider and offshore unit
  • Measure and monitor performance of vendors against service levels and other metrics/KPIs
  • Support with Facilitate operational meetings
  • Develop governance documents, business continuity plan, quality control plan, vendor monitoring plan
  • Establish and maintain collaborative relationships with key stakeholders within CSPV and external functions including Clinical Development, Research & Development, Regulatory Affairs
  • Manage and escalate issues for resolution
  • Participate in inspection and audit readiness activities
  • Provide input for remediating PV system deficiencies cited during inspections/audits
  • Implement effective corrective and preventative action
• 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 Qualifications (from an accredited college or university)

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

Experience Qualifications

• 4 or More Years Drug Safety/Pharmacovigilance experience, including both investigational and marketed products required
• 4 or More Years Direct experience in Pharmacovigilance Agreements, global setting preferred

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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.