Maha Elluri

I am a physician and senior pharmacovigilance professional with hands-on experience in end-to-end pharmacovigilance system management and medical safety leadership. I have led senior-level medical review activities across clinical and post-marketing settings and have first-hand inspection experience with global health authorities including HPRA, MHRA, ANSM, and the FDA. My work spans EU and global PV system oversight, regulatory compliance, and benefit–risk decision-making across the product lifecycle.

Physician and senior pharmacovigilance leader with over 21 years of experience in clinical and post-marketing drug safety across global pharmaceutical organizations. Extensive hands-on expertise in end-to-end pharmacovigilance system management, medical review, signal detection, risk management, and regulatory compliance across the product lifecycle.

Served as Global Safety Director and UK/EEA QPPV, with accountability for EU and global PV system oversight, PSMF governance, inspection readiness, and health authority interactions. Proven experience acting as Marketing Authorisation Holder representative and leading successful pharmacovigilance inspections conducted by HPRA, MHRA, ANSM, and the FDA, with no critical or major findings.

Brings strong medical leadership experience across diverse therapeutic areas including rare and ultra-rare diseases, oncology, CNS, infectious diseases, and chronic conditions. Demonstrated ability to lead and mentor global pharmacovigilance physician teams, oversee vendors and CROs, and collaborate cross-functionally with Regulatory Affairs, Quality, Clinical Development, and Medical Affairs to deliver inspection-ready, compliant PV systems.

Recognized as a speaker and panelist at leading international forums, including the World Drug Safety Congress and global pharmacovigilance and AI conferences, contributing to scientific exchange, regulatory best practices, and thought leadership in drug safety.

Medical Doctor (MD) with postgraduate qualifications including an MSc in Pharmaceutical Medicine from Trinity College Dublin and an MBA in Operations Management. Completed executive leadership training through Cornell University. Ongoing professional development in pharmacovigilance, signal management, risk management, and QPPV responsibilities through DIA and international regulatory forums.