Associate Director, PV Case Management - ICSR

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.   

Job Summary:

This position oversees ICSR Standards activities, projects, and procedures. This level interacts within global CSPV and with CROs, vendors, and partners; and participates on interdepartmental study teams. This level handles escalated global CSPV case processing issue and handles project. This position prepares trainings, supports CAPA investigations, case review, documentation reviews in collaboration with the ICSR management and CRO/Vendor oversight groups for case processing activities and reports to the Director of PV Case Management.

Responsibilities:

• ICSR Processing: Oversees QC activities, supports projects and interacts with the DSI Case Management team / global case management team and partners on a daily and as-needed basis. Management of escalated case processing issues/troubleshooting. Supports CAPA investigations / implementation.

• ICSR Standards Oversight: Acts as subject matter expert in ICSR standards, decision making and trouble shooting. Identifies CRO/vendor training as needed. Reviews overall processes and identifies areas of concern, arranges for remediation. Performs review of data entry convention documents, PVA reviews and SAE flow plan / data management plan reviews. Works with ICSR management and CRO/Vendor oversight to manage relationship with CROs and Vendors.

• Case Processing Policies and Procedures: Reviews, approves, provides input on and authors SOPS, SOIs, and process guides. Participates in inspection preparation activities and internal and external audits and audits CAPA preparation.

• Case Processing Training: Identifies case processing and related CRO/vendor training needs and reviews case processing project specific training materials. Manages and coaches the PV Vendor Training Coordinator.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education:

• Bachelor's degree in nursing, pharmacy, life sciences, health care or related field; required

• PharmD preferred

• Master's Degree Life Sciences preferred Experience Qualifications

Experience:

• 4 or more years of experience in management experience in PV; required

• 10 or more years of experience within Drug Safety/Pharmacovigilance experience, including both investigational and marketed products; preferred

• Extensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD). preferred

• Extensive knowledge of FDA regulations, clinical and safety databases, preferred

• Familiarity 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: