Daiichi Sankyo Inc. • Basking Ridge, NJ 07920
Job #2678099846
Join a Legacy of Innovation 110 Years and Counting!
Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. Summary-This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle Independently leads activities without supervision for assigned clinical studies -Lead activities under the direction of Clinical Safety Scientist Product Lead -Develop expertise in one or more focus areas (SME) -Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation
Responsibilities
Risk Management (Signal identification, evaluation, mitigation):
Supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle
Safety Communication:
Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documents
CTD submissions/Others
May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist Lead, Clinical Safety Physician(s), PSL, and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of CTD
Project Management:
Coordinates SMT/Product-level safety meetings, maintains roster, calendar, and minutes, and communicate materials, in support of the Clinical Safety Scientist Product Lead and PSL
May serve as a project manager for other activities involving assigned product(s) or clinical studies, as needed 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 at minimum required
PhD preferred Experience Qualifications
Possesses scientific or therapeutic area, and drug development knowledge preferred
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
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