Manager Clinical Safety Scientist

4 weeks ago

Basking Ridge, United States Daiichi Sankyo Full time

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 120 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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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 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 lifecycleCollaborates with Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify potential safety signals, tracks safety signals in the global electronic signal tracking tool and performs safety analysis/evaluation. May contribute to safety action recommendations, and communication and risk minimization plans. Presents assessment to the appropriate forums, including Safety Management Team (SMT) or other cross-functional teamsCollaborates with Clinical Safety Scientist Lead and PSL to develop materials (presentation, safety analyses / evaluation, etc.) for SMT/Product-level safety meetingsCollaborates with Clinical Safety Scientist Product Lead and PSL to develop minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs)Collaborates with Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned product

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 documentsCollaborates with Clinical Safety Scientist Lead and PSL to author safety sections of Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)Contributes to regulatory authority requests or communication for assigned clinical studies

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 CTDDevelop expertise in one or more focus areasSupports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as neededInvolved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation

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 PSLMay 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 requiredPharmD preferredPhD preferred

Experience Qualifications

Possesses scientific or therapeutic area, and drug development knowledge preferred0-1 year of experience with an advanced degree required2-3 years of experience with a Bachelor’s degree required

Travel

Ability to travel up to 10%

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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