Director, PV CR0 Management

Director, PV CR0 Management Employer Daiichi Sankyo Location Basking Ridge - NJ Start date May 11, 2026 View more categories View less categories Discipline Clinical , Drug Safety/Pharmacovigilance Required Education Bachelors Degree Position Type Full time Hotbed Pharm Country , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job

Job Details Company Job Details Job Description Job Title:

Director, PV CR0

Management Job Requisition ID:

1491

Posting Start Date:

5/11/26 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 PVMust have proven expertise in Drug Safety / Pharmacovigilance experience, including both investigational and marketed productsExtensive knowledge of AE and drug coding conventions (Med

DRA, WHO-DD

)Extensive knowledge of FDA and familiarity with ROW regulations, clinical and safety databasesMust 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 Download Our Benefits Summary PDF Professionals Company 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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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. For more information, please visit: www.daiichisankyo.com . Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com .

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Tokyo Stock Exchange

STOCK SYMBOL

4568 Company info Website http://www.daiichisankyo.com/ Phone (908) 992-6400 Location 211 Mt. Airy Road Basking Ridge New Jersey 07920 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert