- 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
- 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
- Collaborates 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 crossfunctional teams
- Collaborates with Clinical Safety Scientist Lead and PSL to develop materials (presentation, safety analyses / evaluation, etc.) for SMT/Productlevel safety meetings
- Collaborates 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 documents
- Collaborates 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 crossfunctional team to develop safety strategy, key safety messages, and review and author safety sections of CTD
- Develop expertise in one or more focus areas
- Supports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as needed
- Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation
- Project Management:
- Coordinates SMT/Productlevel 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
- Bachelor's Degree at minimum required
- PharmD preferred
- PhD preferred Experience Qualifications
- Possesses scientific or therapeutic area, and drug development knowledge preferred
- 01 year of experience with an advanced degree required
- 23 years of experience with a Bachelor's degree required TravelAbility to travel up to 10%
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Manager Clinical Safety Scientist - Basking Ridge, United States - Daiichi Sankyo
Description
Join a Legacy of Innovation 110 Years and CountingCompany is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.
Summary
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)
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.
