Dr. Mangesh Nakade PhD sMBA

Drug safety , drug regulatory, clinical research , pharmacovigilance (clinical and post marketing ) -Argus database -Medidata rave -Team handling -AE and SUSAR reporting -1. Timely completion of action items assigned to the PSUR processing team. Based on the information/data provided by GDS, global evaluation and assessment of data for PSUR writing. 2. Medical writing of a succinct summary of all adverse events in the PSUR period, benefit-risk balance of the product in light of any new or changing

a) Case Processor (Local Drug Safety Manager) b) Case Evaluator (Global Drug Safety Manager) c) Managing Global Drug Safety Inbox d) Aggregate report writing (Completed following trainings with example PSUR writing) e)Team Handling Handling time of 30 people of drug safety associate all over the world.

-Evaluate adverse event reports, assesses regulatory status based on seriousness and expectedness/relatedness to prioritize the workload. -Quality Review and Case Processing of Initial and Follow- up ICSR’s. -Managed and Coordinated the workflow at different location -Gained Knowledge in ICSR, GVP Modules, ICH GCP and Drug Safety Guidelines for E2b submissions. -Team handling and management -Act as Trainer for new CRE and case processor - Experts in literature cases -Help in internal and client Audit