Aruri Gowtham

Pharm.D graduate with hospital-based clinical data management experience — data validation, MedDRA coding, query management, and discrepancy resolution across 5 inpatient specialties including cardiology, pulmonology, and general medicine (300+ clinical cases processed).

Built

OpsCore, a clinical data platform with EDC data ingestion (Medidata Rave/Veeva/REDCap), 13 automated data quality checks, CDISC SDTM compliance validation, SAS reader for CDISC SDTM/ADaM data, and audit trail with SHA-256 hashing. Experienced in GCP-compliant documentation, case narrative drafting, and query resolution workflows. Seeking a Clinical Data Management role to apply data integrity expertise and Python/SQL skills at a global CRO.

Pharm.D Clinical Postings — ADR Monitoring - SBMCH&RI - Renigunta, AP

(2023-01 - 2024-12)

• Monitored and reported adverse drug reactions across 5 inpatient specialties, processing 300+ clinical cases with WHO-UMC causality assessment and case narrative drafting
• Performed MedDRA coding for adverse events and medication reconciliation for clinical case data accuracy
• Identified and resolved clinical case-data discrepancies through query resolution with multidisciplinary ward teams — methodology later automated into PV-Trace
• Documented GCP-compliant, audit-ready pharmacovigilance records and safety reports following ICH E2A classification guidelines
• Co-authored peer-reviewed publication (IOSR Journal of Dental and Medical Sciences, Vol. 23, Issue 2, 2024)

Doctor of Pharmacy - Pharmacy - JNTU Anantapur (2018-01 - 2024-12)

Data Science Programme - Data Science - ExcelR Solutions (2025-08 - 2026-05)