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Hemalatha Rajesh

Medical Safety Physician/Medical Reviewer - Data Labeling & Review

India flagChennai, India
Expert

Key Skills

Software

No software listed

Top Subject Matter

Pharmacovigilance Domain Expertise
Medical Safety
Adverse Event Reporting

Top Data Types

TextText
DocumentDocument

Top Task Types

DiagnosisDiagnosis

Freelancer Overview

Medical Safety Physician/Medical Reviewer (Data Labeling/Medical Review for AI/Safety Systems). Brings 30+ years of professional experience across legal operations, contract review, compliance, and structured analysis. Core strengths include Argus Safety, RAVE, and EDC. Education includes Certificate in Artificial Intelligence in Healthcare, Stanford Center for Health Education (2024) and Certificate in Advanced Pharmacovigilance and Argus Safety, CCRPS (2021). AI-training focus includes data types such as Text and labeling workflows including Diagnosis.

Expert

Labeling Experience

Medical Safety Physician/Medical Reviewer - Data Labeling & Review

TextDiagnosis
I conducted regular medical review and signal detection activities on global safety data in a pharmacovigilance setting. My responsibilities included checking case assessment and consistency in the Global Safety Database, prioritizing and managing special case requests, and communicating queries with internal teams. I contributed to event coding, causality assessments, and trained others on related processes. • Performed non-serious line listing for signal detection tasks • Analyzed, interpreted, and implemented client data updates • Reviewed and reconciled case information and queries • Used Argus Safety for structured case management and medical review.

I conducted regular medical review and signal detection activities on global safety data in a pharmacovigilance setting. My responsibilities included checking case assessment and consistency in the Global Safety Database, prioritizing and managing special case requests, and communicating queries with internal teams. I contributed to event coding, causality assessments, and trained others on related processes. • Performed non-serious line listing for signal detection tasks • Analyzed, interpreted, and implemented client data updates • Reviewed and reconciled case information and queries • Used Argus Safety for structured case management and medical review.

2022 - Present

Clinical Research Coordinator and Data Coordinator - Data Labeling

TextDiagnosis
Entered and cleaned electronic clinical trial data, including adverse events, into EDC systems. Validated and reconciled case report forms, resolved system-generated queries, and collaborated with data managers to ensure quality data labeling. Monitored trial data integrity in studies related to psychiatric and gastrointestinal disorders. • Assisted with electronic patient randomization and AE/SAE documentation. • Processed lab data and maintained timely communication with trial personnel. • Managed data discrepancies through internal auditing and CRF reviews. • Utilized RAVE, EDC, and IVRS for clinical data management and labeling activities.

Entered and cleaned electronic clinical trial data, including adverse events, into EDC systems. Validated and reconciled case report forms, resolved system-generated queries, and collaborated with data managers to ensure quality data labeling. Monitored trial data integrity in studies related to psychiatric and gastrointestinal disorders. • Assisted with electronic patient randomization and AE/SAE documentation. • Processed lab data and maintained timely communication with trial personnel. • Managed data discrepancies through internal auditing and CRF reviews. • Utilized RAVE, EDC, and IVRS for clinical data management and labeling activities.

2014 - 2018

Education

C

CCRPS

Certificate in Advanced Pharmacovigilance and Argus Safety, Pharmacovigilance and Argus Safety

Certificate in Advanced Pharmacovigilance and Argus Safety
2021 - 2021
C

CCRPS

Certificate, Pharmacovigilance and Argus Safety

Certificate
2021 - 2021

Work History

Q

Qinecsa Solutions India

Medical Safety Physician

Mysuru
2022 - Present
Q

Qinecsa Solutions

Medical Safety Physician / Medical Reviewer

Mysuru
2022 - Present