Yognidhi Yognidhi

Managing the workflow of routine ICSR cases as well as literature full text articles for assessing reviewing and processing, the results of established literature searches Interact and communicate effectively with other company departments/functions to ensure the highest level of client satisfaction through successful execution of projects. Lead in the development of case management related SOPs and Operating Guides. Mentor and train other associates and MRs on processes

• Preparation of Health Hazard Evaluation report, PADER, PSUR, PBRER • Medical Review of Serious/Non-serious cases • Provide medical evaluation for the cases including medical assessment • Responsible for causality assessment for clinical trial cases

• Medical review of spontaneous and study cases for oncology drugs • Provide medical evaluation for the cases including medical assessment • Verify appropriate selection of seriousness criteria of adverse events • Verify appropriate MedDRA code assignment and accuracy of label assessments

• Clinical Study Document Review • Conduct Site Qualification Visits • Conduct Site Initiation, Monitoring and Close-out Visits • Reconciliation and Management of clinical trial supplies

• Patient screening and enrollment • AE reporting to EC and Sponsor • Maintaining database of the patients for clinical trials • In-house patient care • Attend to casualties independently • Attend to OPD patients