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.Raghunandan has 15 years of experience in Drug Safety (PV), Business Analysis, Computer System Validation, Project Management and with expertise in:• Good knowledge of Pharmaceutical Safety Systems (Argus/ARISg/AERS) which includes E2B Regulations (EMEA/FDA/MHLW etc), ICSR’s, Safety Applications and Database Development/ Implementation/ Maintenance and Validation• Defining the consulting business strategies and plans, building the team with deep levels of Drug Safety and Pharmacovigilance expertise, enabling the project delivery process by leveraging robust standards, methodologies• Identification of gaps in existing business process and redesigning to bring efficiency and effectiveness of critical processes• Experience of executing projects through global programs at different geographical locations • Strategizing and implementing Computer System Validation (CSV) processes for Safety System implementations for clients as per regulatory guidance, industry best practices and company standards• Rich comprehension in Pharmaceutical Regulatory Compliance including FDA cGxP, 21 CFR Part 11 and GAMP 5.0 framework• Validation planning and strategy. Project schedule & tracking, coordinating and managing STLC