Dr. Karthik Muthusamy

Senior Director, Head Expedited Safety Reporting at Bristol Myers Squibb      


Dr. Karthik Muthusamy is a senior director specializing in drug safety operations, risk management and patient safety initiatives. With nearly two decades of expertise in pharmacovigilance and clinical research, he has spearheaded major pharmaceutical integrations and reshaped industry standards through his work with regulatory bodies & industry consortiums. Karthik is an expert in global standards and regulations, specifically FDA regulations on clinical trial safety reporting and has been instrumental in advancing drug safety practices from paper-based systems to modern electronic reporting for expedited safety reports. He has been at the forefront of implementing cutting edge AI & ML applications to modernize drug safety operations.

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Articles from Dr. Karthik

AI in Drug Safety: From Concept to Reality, The Industry's Path Forward

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Pharmaceutical companies are dealing with an unprecedented volume of safety data with artificial intelligence moving from theoretical applications to practical solutions in pharmacovigilance. With the FDA now receiving over two million Individual Case Safety Reports (ICSRs) every year  - a number that has grown quite notably since the pandemic - the industry is facing increasing pressure to modernize its approach to drug safety monitoring.