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
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