Associate Director, PV Case Management at Daiichi Sankyo, Inc. in Basking Ridge, New Jersey

Job Description:

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 16,000 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.



Summary



This position oversees case processing 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, handles project oversight issues, and participates in CRO governance and operational management decisions. This level oversees all mentorship, training, case review, case discussion, with the Strategic Partner vendor for case processing as well as CROs engaged in case processing activities and reports to the Director of PV Case Management).



Responsibilities



- Case Processing: Oversees intake activities (i.e. mailbox management, LP recon, post marketing follow up), 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/trouble-shooting. Supports UAT, submissions and CAPA implementation.
- Vendor Submissions Oversight: Acts as subject matter expert in submissions, decision making and trouble shooting. Identifies and arranges for CRO/vendor training as needed. Reviews overall processes and identifies areas of concern, arranges for remediation. Performs vendor submission QC. Monitors CRO/vendor submissions and submission QC activities to ensure quality completion of deliverables. Lead for PV projects. Works with Strategic Partner Management Lead to manage relationship with CROs and Vendors.
- Case Processing Policies and Procedures: Reviews, approves, and provides input on SOPS, SOIs, and process guides. Participates in inspection preparation activities and internal and external audits and audit 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.
- PV Representative on Study Teams: PV contact for study teams as needed and oversees staff assignments on study teams. 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.
- Aggregate Reports: Participates in the preparation of quarterly Case Processing Compliance and Volume Report. Works with the Aggregate Reports Coordinator to ensure the Case Processing team supports preparation of aggregate reports. Oversees NDA PADERS and IND safety section preparation.



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 in nursing, pharmacy, life sciences, health care or related field; required
- PharmD preferred
- Master's Degree in life sciences preferred



Experience Qualifications



- 4 or More Years of management experience in PV required
- 10 or More Years of 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.