What are the responsibilities and job description for the Associate Director, PV Strategic Partner Management position at Daiichi Sankyo US?
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
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, 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.
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 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 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.
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
Musthave 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
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, 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.
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 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 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.
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
Musthave 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
Salary : $153,600