Manager, Clinical Study Start Up, Pharmacovigilance
3 weeks ago
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 supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of DS Safety Notification Letter (SNL) System and manages uploads to TMF activities. This position will interact with global study teams and represent PV operations in global interactions with CS Physicians and other study team members. This position will also engage within CSPV and with CROs to execute study start up processes.
Responsibilities
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 Science requiredExperience Qualifications
4 or more years drug safety experience with technical experience in Electronic Data Capture and Safety ReportingMust have knowledge and expertise in Pharmacovigilance (PV)7 or more years MS, RN, or PharmD preferred, or total pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development 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.
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