Narayan Tripathi
Senior Director, Pharmacovigilance
Expertise:
Dr. Narayan Tripathi is a seasoned and performance-driven healthcare professional with over 16 years of experience in Pharmacovigilance (PV). Currently serving as Senior Director of Pharmacovigilance at EVERSANA, he leads a team of over 100 safety professionals, overseeing global drug safety operations including ICSR processing, regulatory submissions, safety data exchange agreements (SDEAs), risk management planning, and aggregate authoring.
Dr. Tripathi is recognized for his ability to spearhead large-scale, complex PV assignments, ensuring global compliance across diverse therapeutic areas, including oncology and hematology. His leadership is marked by zero critical/major observations across five regulatory inspections and experience in handling 45-plus PV inspections globally. He has a track record of enhancing quality, compliance and operational efficiency through innovative process improvements and digital solutions and Large Language Models (LLMs) for literature intake automation and other case processing solutions.
He possesses advanced expertise in regulatory intelligence, signal detection, safety surveillance, PASS/IST studies, and PBRER/DSUR/RMP preparation, with a strong focus on inspection readiness and safety governance. In addition to his deep domain expertise, he demonstrates exceptional technological proficiency, with hands-on experience in all leading global safety databases and literature monitoring tools.
Nayaran’s career spans leadership roles at Sun Pharma, Innoplexus (Pfizer Oncology project), Apcer Life Sciences, and Quintiles, reflecting a consistent commitment to compliance, quality and operational excellence. Technologically adept and process-driven, he is passionate about mentoring, cross-functional collaboration, and building resilient, scalable safety systems aligned with global regulatory standards. Dr. Tripathi brings a rare blend of clinical insight, regulatory knowledge and operational strategy, making him a pivotal leader in advancing global PV systems and ensuring patient safety throughout the product lifecycle.
Articles by Narayan Tripathi
Staying Ahead of the Curve in Pharmacovigilance: Mid-Year Pharmacovigilance Inspection Report 2025: Saudi Food & Drug Authority (SFDA)
In an era where patient safety and regulatory compliance are more critical than ever, staying informed about global pharmacovigilance trends is essential. The Saudi Arabia Drug Authority (SFDA) recently released its 2025 Mid-Year Pharmacovigilance Inspection Report, offering a detailed look at inspection outcomes, key findings and areas for improvement. Our experts break down the highlights […]
Staying Ahead of the Curve in Pharmacovigilance: Module VI Addendum II – Masking of Personal Data in Individual Case Safety (GVP)
In an era where patient safety and regulatory compliance are more critical than ever, staying informed about global pharmacovigilance trends is essential. The EMA and PRAC recently released the “Module VI Addendum II – Masking of Personal Data in Individual Case Safety (GVP).” Our experts break down the key takeaways to help Marketing Authorization Holders […]