Clinical Safety Scientist - Lead

Role Overview: As a Clinical Safety Scientist - Lead, your primary responsibility will be to conduct literature reviews to assess ICSR and new safety signals for inclusion in Aggregate reports and DSR (Drug Safety reports). You will also provide MAH comments for selected literature and review Literature Strategy. Additionally, you will be involved in designing and interpreting various types of studies in medicine, assessing levels of evidence, study power for safety analyses, and reviewing outputs triaged by safety scientists for scientific accuracy based on specific criteria. Moreover, you will be responsible for authoring Safety Sections of SSSRs, DSUR, aCO, PBRER, RMP updates, and implementation plans. You will also review various types of listings for Signal Detection. Key Responsibilities: - Conduct literature reviews to assess ICSR and new safety signals - Provide MAH comments for selected literature - Review Literature Strategy - Design and interpret various types of studies in medicine - Assess levels of evidence and study power for safety analyses - Review outputs for scientific accuracy based on specific criteria - Author Safety Sections of SSSRs, DSUR, aCO, PBRER, RMP updates, and implementation plans - Review various types of listings for Signal Detection Qualifications Required: - Bachelor Degree in a relevant field - Experience in Aggregate report and literature review - Proficiency in safety signal, DSR, and ICSR Additional Company Details: The industry type for this role is Pharmaceuticals. This is a full-time, permanent employment opportunity. Other Information: - Job Code: GO/JC/1154/2025 - Recruiter Name: Hariharan,