NITZ Consulting Private limited

Hyderabad, Telangana

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.