Manager, Clinical Safety Scientist
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: June 23, 2022
Job Description:
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 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 preparationResponsibilities
- 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 cross-functional teams
- Collaborates with Clinical Safety Scientist Lead and PSL to
develop materials (presentation, safety analyses / evaluation,
etc.) for SMT/Product-level 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 cross-functional 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/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 neededQualifications:
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
- PharmD preferred
- PhD preferredExperience Qualifications
- Possesses scientific or therapeutic area, and drug development
knowledge preferred
- 0-1 year of experience with an advanced degree required
- 2-3 years of experience with a Bachelor's degree
requiredTravelAbility 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.
Keywords: Daiichi Sankyo, Newark , Manager, Clinical Safety Scientist, Executive , Basking Ridge, New Jersey
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