At Fortrea, I processed adverse event, serious adverse event, and SUSAR cases in Oracle Argus, supporting clinical-trial and post-marketing safety work. I performed case triage, MedDRA coding, narrative writing, quality review, and causality assessment.
I also contributed to PSUR and DSUR preparation, signal detection, and benefit-risk assessment. My work followed FDA, EMA, ICH-GCP, and GVP requirements, with attention to case quality and regulatory timelines.
During my quality assurance internship at Strides Pharma Science Ltd., I performed and observed analytical testing and assisted with process validation, deviation handling, and documentation review. I also supported OPD and IPD dispensing and pharmacy documentation at Anekal Health Care Hospital (Anekal ) (P) Ltd.
