At Fortrea Scientifics, I processed Individual Case Safety Reports (ICSRs) and submitted them to US-FDA, EMA, MHRA, and business partners. I also handled portal, courier, and manual email submissions in CIOMS and MEDWATCH formats.
I reviewed ICSR quality after data entry, documented review results, and participated in project teams working to improve case quality. I also identified error trends and helped identify training needs.
In case processing, I handled adverse-event reports in AgXchange, ARISg, and ARGUS. My work included case intake, triage, data entry, medical coding, narrative writing, follow-up, and regulatory submissions.
Previously, as a Safety Science Analyst at Covance by LabCorp Drug Development, I handled ICSRs in AgXchange and ArisG, including duplicate and invalid case identification. I processed spontaneous, solicited, and literature cases and supported reporting to regulatory authorities.
