I take this opportunity to introduce myself as Md Shahbaz Ashraf, Master of pharmacy in Medicinal Chemistry from Delhi University, India with over 4 years of experience in the field of Pharmacovigilance. I am currently working as Safety Specialist-II in INC Research, a USA based organisation dealing in drug safety and clinical research, since 01/JUN/2015. I have sound knowledge of ARGUS, ARISg and Empirica Trace Database of clinical safety and surveillance with excellent expertise in Medra and WHO coding. Good comprehension of FDA guidelines, Good Clinical Practice (GCP), Guidelines on good pharmacovigilance practices (GVP), International Conference of Harmonization (ICH) and other regulatory guidelines (NDA). I Have strong understanding of Vol 9A, US FDA CFR Part 11 requirement, good understanding of PV audit preparation, presentation, successfully faced multiple Health Authority inspection during the last couple of years, team management along with their training and development and Drug Safety/Pharmacovigilance activities. I bring an excellent understanding of different classes of pharmaceutical products, Medical Devices, Drugs, Supplements and Cosmetics. Receiving, acknowledging, assessing and performing data processing and quality check (QC) of post-marketing safety reports (ADR reports) from United States, Canada and European Union into the database. Good knowledge of medical and scientific information. Good knowledge of computer as per the pharmaceutical application.