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Dr. Darshan Bhatt
Advisor Medical and Drug Safety
Brief info:

Darshan is a postgraduate in Aerospace Medicine and holds an M.Phil. degree in Hospitals and Health Systems Management from BITS, Pilani, India. He has 22 years of clinical experience and applied biomedical research while serving the Indian Air Force and after that more than 20 years of experience in pharmaceutical industry.

He worked for 10 years with AstraZeneca to provide strategic inputs to drug discovery and development in India and UK. At AstraZeneca UK, as the Global Drug Safety Physician he was member of Clinical Development Teams for Cardiovascular and Inflammation therapy areas and was responsible for the safety of subjects from First in Man studies to Phase III programme. He represented the company in discussions with the FDA and EMEA at the End of Phase II programme in development of Ticagrelor and to strategize the design of Phase III study. He also successfully handled the pharmacovigilance responsibilities of marketed products. He was also involved in harmonization of SmPC and labelling of ACE-inhibitors and developing the SOP for writing Patient Risk Management Plans. 

After his return to India in 2006, he helped set up KPO services in India namely Sciformix Technologies and MMS Holdings (clinical Research) and in 2010-11 he helped Strides Arcolab Pvt. Ltd. to set up their in-house Pharmacovigilance Operations. 

In 2011 he became Director Drug Safety for Vanthys Pharmaceuticals (An Eli Lilly-Jubilant Research venture)

From Oct 2012 to Feb 2015, he became the senior partner in Quality Systems and a mentor for a team of physicians at Sciformix. He was the main architect to set up CosmetoVigilance Program for a MNC client. Between 2017 and 2019, he was involved in set up and training for the practice of Aggregate Reporting, Signal Detection and Risk Management at Sciformix.

He has been invited to speak on various topics in Drug Development, Clinical Research and Pharmacovigilance and has conducted several hands-on workshops in Pharmacovigilance including those organized by DIA.

He has chaired the Data & Safety Monitoring Board for several clinical studies.