Verified Job
Work from home
Drug Safety Scientist
Work from home
#195081
Remote / WFH
Job Description
• Quality review of ICSRs, surveillance of known or emerging safety issues, participation in an escalation process, risk evaluation, and analysis of safety data.
• Apply safety concepts and regulations contained within FDA CFR, ICH, and EU GVP to management of Safety data across the development life cycle.
• Analyze aggregate safety data within a clinical program towards tracking and trending of risk assessments and additional mitigation measures.
• Contributes to safety sections of the investigational new drug and new drug applications, investigator or regulator communications, Investigator brochure, and other reports (DSUR)
• Participates in the set-up and maintenance of adverse event processes in global clinical trials
• Ensure Quality of the Individual Case Safety Report, including data and a concise, medically relevant narrative.,
• Apply safety concepts and regulations contained within FDA CFR, ICH, and EU GVP to management of Safety data across the development life cycle.
• Analyze aggregate safety data within a clinical program towards tracking and trending of risk assessments and additional mitigation measures.
• Contributes to safety sections of the investigational new drug and new drug applications, investigator or regulator communications, Investigator brochure, and other reports (DSUR)
• Participates in the set-up and maintenance of adverse event processes in global clinical trials
• Ensure Quality of the Individual Case Safety Report, including data and a concise, medically relevant narrative.,
