What are the responsibilities and job description for the Director, PV CR0 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
This position oversees case processing activities, staffing, processes, procedures, and interdepartmental projects involving PV case processing. Responsibilities include management and governance for the case processing CRO covering KPI, training, budget, contracts, and relationship management documentation. This position collaborates within CSPV, DSI interdepartmental teams, global teams, and interacts with CROs, vendors, partners, and study teams on all aspects related to case processing. . This level manages case processing issues, escalating to senior management, as needed. This level participates in hiring, compensation and personnel management decisions.
Responsibilities
ICSR Processing: Oversees daily case processing staff assignments, activities, and projects. Interacts with vendors, CROs, DSI Call Center, and other partners on a daily and as-needed basis. Escalates issues and develops resource strategy with senior management. Oversees CAPA implementation. Oversees metrics and management of staff administration including work schedules, rewards and discipline. Conducts mid-year and annual performance reviews of direct reports, contributes to compensation and hiring decisions. CRO Oversight: Lead for PV CRO/vendor projects and ongoing management oversight including KPIs, training, budget, contracts, and governance documents. Monitors CRO/vendor reports (daily, weekly, monthly as required by project) to ensure quality completion of deliverables. Responds to and manages escalated issues. Identifies and arranges for CRO/vendor training as needed. Works with Contract &Partner Management Lead to manage relationship with CROs and Vendors. Case Processing Policies and Procedures: Reviews, approves, and provides input on SOPS, SOIs, process guides, PV Agreements. Participates in audit/inspection preparation, conduct and CAPA preparation. Management Strategy and Goals: Develops PV goals, continued compliance and strategy for process improvement initiatives with senior management and PV management team. PV Representative on Study Teams: Case processing contact for study teams as needed. May attend multidisciplinary study team meetings and provide management oversight of initiatives and trouble shooting. Participates in Study Start up activities related to case processing as needed including review of SAEFPs, Protocols, and other study related documents. Represents PV for review and comment on interdepartmental and CRO/vendor and partner projects. Case Processing Training: Reviews and approves case processing training materials and training curriculum Identifies case processing and related CRO/vendor training needs and reviews and approves case processing project specific training materials.
Qualifications
Education Qualifications
Bachelor's Degree in nursing or health care related field required
Experience Qualifications
Minimum of five (5) years of management experience in PV
Must have proven expertise in Drug Safety / Pharmacovigilance experience, including both investigational and marketed products
Extensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD)
Extensive knowledge of FDA and familiarity with ROW regulations, clinical and safety databases
Must have Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).
Travel Requirements
Ability to travel up to 10% of the time domestic and international.
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$201.840,00 - USD$302.760,00
Job Summary
This position oversees case processing activities, staffing, processes, procedures, and interdepartmental projects involving PV case processing. Responsibilities include management and governance for the case processing CRO covering KPI, training, budget, contracts, and relationship management documentation. This position collaborates within CSPV, DSI interdepartmental teams, global teams, and interacts with CROs, vendors, partners, and study teams on all aspects related to case processing. . This level manages case processing issues, escalating to senior management, as needed. This level participates in hiring, compensation and personnel management decisions.
Responsibilities
ICSR Processing: Oversees daily case processing staff assignments, activities, and projects. Interacts with vendors, CROs, DSI Call Center, and other partners on a daily and as-needed basis. Escalates issues and develops resource strategy with senior management. Oversees CAPA implementation. Oversees metrics and management of staff administration including work schedules, rewards and discipline. Conducts mid-year and annual performance reviews of direct reports, contributes to compensation and hiring decisions. CRO Oversight: Lead for PV CRO/vendor projects and ongoing management oversight including KPIs, training, budget, contracts, and governance documents. Monitors CRO/vendor reports (daily, weekly, monthly as required by project) to ensure quality completion of deliverables. Responds to and manages escalated issues. Identifies and arranges for CRO/vendor training as needed. Works with Contract &Partner Management Lead to manage relationship with CROs and Vendors. Case Processing Policies and Procedures: Reviews, approves, and provides input on SOPS, SOIs, process guides, PV Agreements. Participates in audit/inspection preparation, conduct and CAPA preparation. Management Strategy and Goals: Develops PV goals, continued compliance and strategy for process improvement initiatives with senior management and PV management team. PV Representative on Study Teams: Case processing contact for study teams as needed. May attend multidisciplinary study team meetings and provide management oversight of initiatives and trouble shooting. Participates in Study Start up activities related to case processing as needed including review of SAEFPs, Protocols, and other study related documents. Represents PV for review and comment on interdepartmental and CRO/vendor and partner projects. Case Processing Training: Reviews and approves case processing training materials and training curriculum Identifies case processing and related CRO/vendor training needs and reviews and approves case processing project specific training materials.
Qualifications
Education Qualifications
Bachelor's Degree in nursing or health care related field required
Experience Qualifications
Minimum of five (5) years of management experience in PV
Must have proven expertise in Drug Safety / Pharmacovigilance experience, including both investigational and marketed products
Extensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD)
Extensive knowledge of FDA and familiarity with ROW regulations, clinical and safety databases
Must have Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).
Travel Requirements
Ability to travel up to 10% of the time domestic and international.
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$201.840,00 - USD$302.760,00
Salary : $202