Physician by profession and a global leader with expertise and experience more than 15 years in drug safety and pharmacovigilance regulatory affairs with additional experience in medical writing, clinical trials, BA/BE monitoring, and auditing. Well-versed in global regulatory guidelines and speaker at national and international conferences. Strong manager known as a keen planner, strategist, and implementer with solid track record of results that deliver business value through streamlined PV operations. Audited many pharma companies as third-party auditor. Extensive experience in USFDA and MHRA inspections, and acting as a consultant for regulatory inspections with a good inspection outcome. One of the leading PV expert(consultant) in India. Vision is to make Indian companies prepared for inspection with no or minimal findings.

Subject matter expert for pharmacovigilance operations with overall experience of 10 years. Strong leadership skills with extensive working knowledge on ICSR processing (Clinical trials, Spontaneous Reports, Literature, PMS, pregnancy, etc), regulatory reporting, E2b requirements, monitoring dedicated safety mailboxes and quality management systems. Expertise on Argus database, gateway set up and data migration. Understanding of EU, US, Indian requirements. Quality driven approach and have represented PV operations in multiple regulatory and third-party inspections.