Dr. Bhuvaneswara Reddy

Individual case review (ICSR) of spontaneous, clinical trial and literature medicinal products. Assessment of causality, seriousness, Medra coding, labelling, SUSAR's Signal detection and evaluation. Aggregate reporting activities (PBRER/PADER/PSUR)/Risk management activities. quality team coordinator. Audit Inspection readiness coordinator for the Physician team (Internal as well external regulatory authorities)

1. Performing medical review of serious adverse event ICSR (Individual case safety reports) cases for marketed product, study medications and literature. Check for proper Medra coding, event selection, labeling, seriousness, causality assessment, SUSAR's, and AOSE (Analysis of similar events). 2 Assessment of PSUR/PBRER (Aggregate reporting) 3. Signal detection and evaluation. AOSE (Analysis of similar events). 4. Training activities

Assessment ICSR's (Individual case safety reports) for causality, Medra coding, seriousness, labelling, SUSAR and Analysis of similar events (AOSE) for all marketed products, clinical trials and literature screening Aggregate reports assessments (PBRER/PSUR/PADER). Signal detection and Evaluation. Experienced in Risk management plans and assessments. Mentor and trainer for New joined Physicians. Member in Audit inspection readiness for physician team.

General Physician