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.,
💡 Quick Summary
Seeking a career-building opportunity? The Drug Safety Scientist position is now open for candidates interested in the Remote Jobs sector. This role in Hyderabad offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Remote Jobs is a plus.
