Review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment, including coding, assessment of seriousness, expectedness, and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events. To support the Qualified Person for Pharmacovigilance in the medical understanding and evaluation of any safety issues and to review articles and database outputs.