PV Manager, Case Management
Daiichi Sankyo, Inc.

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 15,000 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 performs and functions as the subject matter expert in ICSR processing and strategic partner/CRO case processing oversight. This position has potential primary responsibility for the daily workflow monitoring of incoming ICSRs, in-line QC of ICSRs, SAE reconciliation, daily ICSR inquiries from CROs/vendors, ICSR CAPA generation, and support in audits and inspections. CRO Case Processing Oversight includes case mentorship; case quality review, training material development. This level interacts with the CSPV team and has interactions with other DS affiliate sites. This level also interacts and participates on interdepartmental teams and reviews and troubleshoots CRO/vendor case processing. This position is responsible for handling complex spontaneous and clinical ICSR issues, internal and external case processing inquiries, escalating problems to PV management as needed.

ROLE RESPONSIBILITIES

• Case Processing: Serves as the subject matter expert for this area, conducts complex case processing, review, and submission of ICSRs. Performs Triage and review of Local Labeling and Bulk Reporting Argus functions. Adverse event case processing for clinical and spontaneous cases, including case data collection and entry into the global safety database. Entry includes medical history, laboratory data and concomitant and co-suspect drug products. Includes the review and evaluation of event(s) to determine seriousness criteria and listedness according to DS product information. Requires knowledge and use of MedDRA and WHO-Drug dictionaries for coding of adverse events, medical history, lab data and co-suspect and concomitant medications. Ensures case details are complete, initiates follow up on reports as needed, and prepares adverse event reports, including Analysis of Similar Events (AOSE) as applicable, and submissions to partners, investigators, and as required ensuring compliance with regulatory reporting. Performs change request (CR) user acceptance testing (UAT). Assist with submissions and ensure on time submissions including distribution of safety notification letters (SNL) to vendors.
  
• CRO/Vendor Case Processing Oversight:. Mentors and acts as a subject matter expert in case processing procedures with Strategic Partners and CROs engaged in case processing activities. Daily oversight of inquiries, troubleshooting, and coordination of issue resolution. Samples and reviews cases according to Quality Plans including the review and evaluation of all case entries to ensure accuracy. Guides the Strategic Partner in any case related corrections required. Provides mentorship to the Strategic Partner and determines mentorship planning and scheduling. Independently manages all case related issues with the Strategic Partner and CROs engaged in case processing activities. Escalation to Strategic Partner Management as appropriate for partnership related issues (i.e. SLA). Monitors strategic partner and CROs engaged in case processing activities performance, identifies areas for improvement and coordinates improvement initiatives.
  
• Workflow Monitoring Designee: Monitors incoming cases received from CROs, cases in active workflow including pending follow-up, and facilitates timely completion of case processing activities.
  
• Case Processing Training: Participates in developing and delivering case processing training to case processing staff , mentoring new hires and vendors as needed. Collaborates with CS Physicians on protocol related and other training materials.
  
• ICSR Quality Control Designee: Performs in-line quality control of cases within the Argus workflow, documents QC findings, provides feedback of QC findings, compiles monthly QC metrics, offers insights for continuous case processing improvement.
  
• Case Processing Policies and Procedures: Participates in development and update of case processing process guides, SOP/SOIs. Ensures consistency with global procedures and applicability to CRO/vendor case processes to ensure success.
  

• Bachelor's Degree in nursing, pharmacy, or healthcare related field required
  
• Master's Degree preferred
  
• PharmD preferred
  

• 4 or More Years of PV experience and strong knowledge of FDA regulations, clinical, and safety databases with direct experience in case processing oversight and vendor relationship management required
  
• Supervisory/management/project manager experience required