Subodh Bhardwaj

Subodh Bhardwaj

Consultant

Dr Subodh Bhardwaj is a Physician and Clinical Pharmacologist with 30 years of experience leading research, development and pharmaco-vigilance across varied therapeutic areas with Sanofi group, Serum Institute of India, Arable Corporation USA & Surgipharm Uganda. He is MBBS from Medical College Jammu India (1981) and following 7 years in Internal Medicine, he was awarded- MD Pharmacology from the prestigious AMU, India (1990). His initial work included pioneer studies of epidemiological profile of adverse drug reactions in India in 1988 with the ICMR, where he also researched trace elements, hypertension and Diabetes mellitus. He joined the industry in 1993 and then diversified across pharmacovigilance of r-DNA infertility drugs, Growth hormone/ Somatostatin Viral and Bacterial vaccines, Mabs for Rabies & ONCO-BCG for superficial bladder cancer, Meningococcal & pandemic, seasonal influenza vaccines. Leading pharmacovigilance in association with WHO Biologicals he assisted teams to investigate SAEs, SUSARS, and spontaneous AEs globally.

As Director Scientific affairs, Regulatory affairs & Public policy with Sanofi Pasteur he headed the PV operations in India for all licensed products and AEs during clinical trials on INDs, post marketing AEs for all products according to EU/ USFDA regulations reporting to GPVD, Lyon ensuring high standard of compliance & product life cycle management. Well versed with pharmacovigilance principles & practices including Audit- he chaired the Pharmaco-vigilance & clinical trials 4th International conference in London in 2015 -conducting a workshop on Vaccine vigilance. He has planned and conducted more than 50 multicentric, multi-country ICH-GCP Compliant clinical trials including a large sample size post marketing phase IV study (MMR) on 500,000 Egyptian children. He has 60 publications in peer reviewed National and International journals and recently authored a chapter in Pharmaceutical Medicine & Translational Clinical Research published by Elsevier in 2018. He is Member BRAPP, ESOP, Phd guide, and currently works as an Independent Global Biopharmaceutical consultant in New York with acclaimed agencies sharing his knowledge on topics of clinical research and pharmaco-vigilance.

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