Sophos is a global professional services company which provides best in class solutions in the area of Drug Safety and Pharmacovigilance. Focused exclusively on clinical and post-marketing drug safety and surveillance and risk management services and solutions; our expertise in Pharmacovigilance solutions include Oracle® Argus Safety™ Suite, ArisGlobal® ARISg, Oracle® AERS, Empirica Trace and other commercial drug safety systems. From simple software selection to business process redesign, all of our services and solutions are delivered with precise, timely and cost-effective execution to help our clients achieve lower operational costs, minimize potential litigation costs and manage risk.Shailender is Vice President, Pharmacovigilance and Drug Safety at Sophos with expertise in:• Argus Safety Application Suite SME 6x, 7x and 8x• Experience of executing projects through global programs at different geographical locations• Helping CROs win new customers with reduced implementation and running cost. As a result of which, they were able to offer competitive price• Proven expertise in Regulations (EMA, FDA and PMDA)• Argus Implementation, upgrades, patches and data migration• Strategizing and implementing the validation approach and processes as per industry best practices and company standards• Computer System Validation / 21 CFR Part 11 and Root Cause Analysis (RCA) on process deviations/Quality issues• Argus data modeling for custom safety marts including Safety, Insight, DLP and Argus mart• Designing solutions for top Pharmaceutical and Biotech companies• Safety reporting expertise involving OBIEE, Cognos, BO, Qlik view and Spotfire• Designed the global workflow for a Japan based global pharmaceutical company having operations in United States, Europe and Japan