Clinical Safety Scientist - Lead

Role Overview: You will be responsible for conducting literature review to assess ICSR and new safety signals for inclusion in Aggregate report and Drug Safety reports. Additionally, you will provide MAH comments for selected literature and review Literature Strategy. Your role will also involve designing and interpreting various types of studies in medicine for safety analyses and ensuring scientific accuracy of outputs triaged by safety scientists. You will be authoring Safety Sections of SSSRs, DSUR, aCO & PBRER, as well as RMP updates & implementation plans. Reviewing various types of listings for Signal Detection will also be a part of your responsibilities. Key Responsibilities: - Conduct literature review for ICSR and new safety signals - Provide MAH comments for selected literature - Review Literature Strategy - Design and interpret studies in medicine for safety analyses - Ensure scientific accuracy of outputs triaged by safety scientists - Author Safety Sections of SSSRs, DSUR, aCO & PBRER - Author RMP updates & implementation plans - Review various types of listings for Signal Detection Qualifications Required: - Bachelor's Degree - Experience in Aggregate report, Literature review, safety signal, ICSR, DSR - Strong skills in safety signal, DSR, ICSR Note: No additional details of the company were provided in the job description.,