Headline

Medical Data Reviewer | ICSR • MedDRA • eCRF • EDC • EHR • EPIC • ICD-10 / CPT / HCPCS | Oncology Data Abstraction | NCCN/ASCO/AJCC/HIPAA | Adverse Event Analysis • Safety Reporting | Clinical Data Management |

About

Medical Data Reviewer and IPQA officer with 3+ years of experience in clinical data abstraction and regulatory compliance across oncology and pharmaceutical domains. I currently worked in Omega Healthcare Pvt Ltd, Bangalore, I manage Individual Case Safety Report (ICSR) processing — including MedDRA and WHO-DD coding, adverse event analysis, seriousness and causality assessment, and safety database management — in full compliance with ICD -10, HCPCS and NCCN , AJCC Guidelines requirements. I have maintained 99.97% data accuracy while supporting audits, quality improvement initiatives, and NCCN/ASCO-aligned clinical reporting. Prior experience as an IPQA Officer at Seegakula Pharmaceuticals provided a strong grounding in GMP-regulated environments, in-process quality control, and batch documentation. Core skills: ICSR Processing • MedDRA • EDC/EHR/eCRF • Adverse Event Analysis • Safety Reporting • Oncology Data Abstraction • Risk Management • Data Curation & Quality Analysis Education: B.Pharm, SSCP Tumkuru | Advanced Diploma in Clinical SAS (Clinical Research & CDM) Open to roles in Pharmacovigilance, Clinical Research, Data Annotator and Clinical Data Management

Location

Greater Bengaluru Area

Work experience

Clinical Data Abstractor at Omega Healthcare Management Services, Jan 2024 - Jan 2026 · 2 yrs 1 mo, Bengaluru, Karnataka, India, Medical Data Reviewer acts as a quality control specialist for clinical trial data, ensuring that the information used for analysis and submission to regulatory authorities is reliable and trustworthy.

Quality Assurance Officer at SEEGAKULA PHARMACEUTICALS PRIVATE LIMITED, Sep 2018 - Feb 2020 · 1 yr 6 mos, Tumakuru, Karnataka, India, An IPQA Officer (In-Process Quality Assurance Officer) is a professional who ensures that products, particularly in the pharmaceutical are manufactured according to strict quality standards. Their main role is to monitor the production process from beginning to end to prevent quality issues before they arise.

Education

Bachelor of Pharmacy - BPharm, Medicine, Siddagnaga College of Pharmacy