Karthik Babu P S | Global PV Operations & PV Partner Markets Head
Opella Healthcare

Dr. Karthik Babu is a Pharmacovigilance (PV) expert with a clinical background and over two decades of experience spanning clinical research and global pharmacovigilance operations. He holds a Bachelor of Ayurvedic Medicine and Surgery (BAMS) and an Executive MBA from the Indian Institute of Management, Lucknow. He leads Global PV Operations & PV Partner markets at Opella (formerly the Sanofi Consumer business unit). Prior to this, he oversaw pharmacovigilance activities for all Sanofi entities across the South Asia region. Before joining Sanofi, he held global PV assignments with Cognizant, TCS, and Accenture, supporting Boehringer Ingelheim, Roche, and Bristol Myers Squibb. Dr. Karthik Babu has led the South Asia region within the International PV Strategy Group of the European Federation of Pharmaceutical Industries and Associations (EFPIA). He is an active member of the PV Council of the Indian Society for Clinical Research (ISCR), where he served as Chair from 2019 to 2022, and is an active member of ISoP North America.

Appearances:

Day 1: 14th October @ 14:05

Panel 6 – Safety and Risk Management for Inspection Readiness in the AI Era

As artificial intelligence (AI) continues to transform pharmacovigilance, organizations must strike the right balance between innovation, regulatory compliance, transparency, and patient safety. As AI technologies continue to reshape the way organizations operate, a key question emerges: How should inspection and audit readiness evolve in the age of AI? More importantly, How can AI itself become an enabler of continuous inspection readiness, helping organizations remain audit-ready at all times while improving efficiency, compliance, and patient safety?

Join industry leaders at the World Drug Safety Congress Americas to explore the evolving role of AI in drug safety and its impact on inspection readiness, governance, and risk management.

This session will examine critical topics including AI governance frameworks, model explainability, data integrity, and the importance of human oversight in modern pharmacovigilance systems. Discover how organizations can leverage continuous inspection readiness strategies, real-time analytics, and cross-functional collaboration to strengthen compliance and enhance decision-making across safety operations.

Learn practical approaches for integrating AI, real-world evidence, and patient insights into pharmacovigilance processes while meeting evolving global regulatory expectations. Gain valuable perspectives on maintaining transparency, traceability, and accountability in AI-enabled environments.

Join us to explore best practices, emerging regulatory expectations, and actionable strategies that will help your organization prepare for the future of AI-enabled inspections and safeguard patient safety in an increasingly digital world.

Priyanka Chhikara, Senior Director, Head of Global Risk Management, Aggregate Reports and PV Data Science, CSL Behring

Aysha Amman, Senior Director, Patient Safety & Pharmacovigilance, Amneal Pharmaceuticals

Moderator: Joan D'souza, Local QPPV, JD Pharma Services

Kal Elhoregy, Independent Global Pharmacovigilance & Quality Risk Management Expert, Independent

Manjiri Nirgudkar, Director, Global Risk Management, Bristol Myers Squibb

Karthik Babu P S, Global PV Operations & PV Partner Markets Head, Opella Healthcare

last published: 24/Aug/26 22:15 GMT

back to speakers