Damon Kelly

Led global pharmacovigilance operations for Phase I–IV trials and post-marketed products, improving SAE review quality and ensuring timely regulatory reporting to FDA and EMA. Trained and mentored safety staff and supported audit readiness across safety databases.

Managed adverse event intake and medical information for marketed and investigational oncology products, ensuring timely regulatory submissions and accurate responses to healthcare professionals. Collaborated with medical review and cross-functional teams on safety matters.

Processed and quality-reviewed adverse event reports, supported signal detection and aggregate safety reporting, and assisted with regulatory response preparations to maintain data accuracy and compliance.

Prepared submission-ready ICSRs in compliance with client and regulatory standards, conducted follow-up to obtain complete safety information, and contributed to PSUR/DSUR preparation and safety reporting.

Responded to medical inquiries from healthcare professionals and patients with clinically accurate dosing and safety information, triaged adverse events in real time, and initiated safety documentation and escalation when needed.

Executed Phase I–IIa protocols including IV starts, ECGs, blood draws, and specimen collection; monitored subjects for adverse events and ensured GCP-compliant documentation and expedited SAE reporting.

Led EMS crew as Saturday Night Crew Chief responding to high-volume emergency calls, triaging and stabilizing patients and coordinating hospital handoffs during acute crises.

Licensed Practical Nurse credential issued by the New Jersey Board of Nursing authorizing practice as an LPN in New Jersey.

Completed a Practical Nursing Diploma program preparing for licensure and clinical practice as a Licensed Practical Nurse.