Responsible for performing medical review for any or all of the following according to the client Standard Operating Procedures and guidelines: review of aggregate reports (e.g. Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs) and Safety Assessment Reports (SARs). Ensuring medical accuracy of documents that are reviewed.
• A degree in Western Medicine • Should have 3 to 5 years of relevant experience in authoring and reviewing of aggregate reports (PSURS/PBRERs, PADERs, RMPs and DSURs). If person has worked on innovator drugs then it would be an advantage • Good knowledge of medical terminology