

Dynamic and detail-oriented professional with experience as a Duty Doctor and Pharmacist at Sri Shakthi Nursing Home. Proficient in clinical research and regulatory affairs, with strong communication skills. Successfully contributed to drug utilization reviews and ensured compliance with ICH-GCP guidelines, enhancing patient safety and care quality.
Clinical Research: Knowledge of all four clinical trial phases, protocol design, and ICH-GCP guidelines
Pharmacovigilance: ADR reporting, case processing, narrative writing, MedDRA coding, and SAEmanagementRegulatory Affairs: Knowledge of IND, NDA, ANDA, dossier preparation, and submissions (CDSCO, FDA)Medical Writing: Experience in writing protocols, CRF, ICF, and patient information leafletsClinical Data Management: Query management, SAE reconciliation, and data reviewDrug Utilization Review: Understanding of DUR/DUE and case documentation as per HIPAA regulationsTechnical & Communication: Proficient in MS Office (Word, Excel, PowerPoint); strong communication and team work skills
PROJECT:A STUDY ON SAFETY AND EFFICACY OF PIOGLITAZONE VERSUS VOGLIBOSE ADJUNCTS TO GLIMEPERIDE AND METFORMIN IN TYPE 2 DIABETES MELLITUS: A CLINICAL COMPARISION
CERTIFICATION:
1.European Journal Of Biomedical and Pharmacetical science
2.Advanced Program in Clinical Research & Management, CLINI INDIA, Hyderabad .
Modules: Pharmacovigilance, Clinical Trial Management, Clinical Data Management, and Regulatory Affairs