Professional Summary:A Techno functional professional with 14 years experience in Pharmacovigilance and HealthCare Domain. As a drug safety IT professional, demonstrated expertise in requirements gathering, analysis, Implementation consultant, testing, validating, reporting, strategizing, implementing and managing life sciences products.• Hands on in Drug Safety Systems (Arisg/J, LSMV, Argus, E2B Gateway, agXchange ESM, agXchange IRT/OST and agConvert products).• Hands on experience on E2B R3(Drug, vaccine and Device), eMDR , MIR ,E2B R2 reporting etc.• Proven experience in client interaction, customer relations, remote management of offshore teams and agile team management.• Global Pharmacovigilance Business Process, EU PV regulations & requirements. Excellent analytical skills and creativity in proposing multiple options/solutions to a requirement, and select the best based on various priorities like time for development, usability, maintainability, etc• Hands on experience in System programming, Application programming, Object oriented programming etc.• Key responsibilities include tracking and monitoring project progress, status reporting to stake holders in order to ensure project delivery is within schedule and quality. • Hands on experience in Project execution including resource allocation, effort estimation, timelines and deliverables, coordination with multiple teams (both on-site and offshore) etc.Specialties: HL7 version 2.x & 3, EMDR, 21 CFR Part 11, MedDRA ,(ICH E2B, MedWatch, CIOMS).Technical Skills:Operating Systems: Windows Server 200x, Linux and UNIXDatabases: ORACLE, MYSQL,PostgreSQLLanguages: C, C++ 14Scripting Languages: Shell scripting,Python,PHP etc.,Tools Known: CVS, Eclipse, Visual studio 6.0 & 2005, SQL Devleloper,Toad, GDB, Visual Source Safe, Bug Zero, Rational rose and Valgrind etc.,Libraries used: Wxwidgets, X library, Roguewave STL, Xerces, tiny xml, tiny xpath, Pthread, sockets, RPM, MFC,Boost etc.,
Listed skills include Unix, C++, C, Xml, and 20 others.
