Harsha Chickballapur | Senior Director
Alnylam

Experienced drug safety and regulatory systems leader with a strong track record of managing multiple software vendors and ensuring validated application states throughout the software lifecycle. Deep expertise in global regulatory requirements, including FDA, MHPD, EMA, and E2B standards for clinical trials and post-marketing safety reporting. Proven ability to enhance operational efficiency through innovative solutions such as automated communications and smart narratives, reducing errors and saving time. Skilled in bridging business and IT functions, serving as a key liaison between Drug Safety and Pharmacovigilance (DSP) and IT teams to ensure timely and compliant application changes. Led and contributed to numerous regulatory and safety projects including E2B transition, data reconciliation, product library reconfiguration, and workflow/report development. Collaborated closely with cross-functional drug safety teams to configure and maintain critical applications (Argus Safety, Empirica Signal, Axway, Intake system) in alignment with compliance standards. Demonstrated expertise in validation documentation (IQ, OQ, PQ) and maintaining validated states during system changes, ensuring regulatory readiness and operational integrity. As a speaker at the World Drug Safety Congress Americas 2025, Harsha will share his insights on how innovation, technology, and performance can empower safety professionals and their partners to navigate the evolving landscape of drug safety. Attendees can expect to gain valuable knowledge and practical strategies from his session.