At Quantum Leap Healthcare Collaborative, I support clinical safety operations for Phase I/II oncology trials in the I-SPY portfolio, including I-SPY 2 and I-SPY DCIS. My work spans case processing, safety-data review, and coordination with sites, CRAs, and cross-functional stakeholders.
I process and review ICSRs in Argus, including triage, MedDRA coding, documentation, and case-completeness review. I also lead recurring Clinical Safety–CRA calls to resolve safety queries and AE/SAE discrepancies.
For newly initiated investigational-product cohorts, I conduct enhanced safety surveillance and escalate clinically relevant findings for multidisciplinary review. I also review external safety information and contribute safety content for Investigator Brochure and Informed Consent Form updates.
Previously, at Clarivate / ProQuest, I conducted oncology literature surveillance for MSD/Organon products, screening 500+ articles per month. At PrimeVigilance, I managed post-marketing ICSRs in Argus and supported regulatory submission workflows; I also served as interim Team Lead during a transition of literature-search activities.
