Primary business, application and functional consultant on Aris Global customer client projects, providing expertise in developing business processes, configuring applications, and implementing ArisGlobal software systems; ensuring that project deadlines and deliverables are met according to time and budget constraints, ensuring the projects adhere and comply with the Aris Global Project Rapid Implementation Methodology and advising on best practices to meet business needs.Responsibilities:• Manage multiple implementation projects and provide technical/project guidance. • Serve as the main contact for the customer on projects. • Perform implementation and test tasks as specified within the project plan• Understand and analyze customer requirements• Provide timely communications to the project manager or project lead on any issues that need to be escalated• Provide validation and training services to customers• Communicate with customers concerning product release dates, new versions and the resolution of documentation problemsInvolved in the following assignments as lead consultantSwedish Medical Products Agency (MPA), Uppsala, SwedenImplementation of ARISg 6.5.x, ESM, agVet• Conducting workshops for Workflow, Distribution rules, configuration requirements• RD Preparation and Review• Conducting training• Architecture planning• Implementation, installation, configuration, upgrades • Technical support to ARISg, E2B Gateway• Validation support, testing• E2B transmission: configuration and testing LEO Pharma, Copenhagen, DemarkImplementation of ARISg 6.3.x, ESM• Requirements gathering• RD Preparation and Review• Architecture planning• Implementation, installation, configuration, upgrades • Technical support to ARISg, E2B Gateway• Validation support, testing• E2B transmission: configuration and testing AFSSAPS (ANSM), Saint Denis, FranceImplementation of ARISg 5x, E2B Gateway 3xGuerbet, Villepinte, France

Consultant specialized in Validation of Computerized Systems,During six years, I completed multiple Validation projects for several pharmaceutical companies, fulfilled different roles and assignments including project management, responsible for Validation project, writing User Requirements specifications and risk analysis, evaluating vendors answers, 21 CFR Part11 compliance audit. My role included complete system validation, creating validation plan, qualification protocols and scripts, executing tests, writing reports and Standard Operating Procedures. The assignment history below is an extract mentioning some project assignments.Laboratoires Besins Healthcare – France, BelgiumProject Lead – Implementation and Validation of ARISg 5.0, data migration and electronic submissionAVENTIS Pharma (Sanofi Aventis) – Croix de Berny, FranceLead validation of Safety system Data MigrationGlobal Pharmacovigilance and Epidemiologic System (USA, France, Japan, Germany)INNOTHERA – Arcueil, FranceSenior Consultant - Benchmarking Pharmaco and Materio Vigilance systems.NOVO NORDISK – Chartres, FranceValidation consultant – project: SCADA system for new production siteIPSEN BEAUFOUR – Paris, FranceValidation consultant: Clinical trial management system

As a qualified instructor certified by Microsoft, I delivered a full suite of Microsoft Certified Training programs throughout France for Microsoft Certified System Engineer (MCSE) programs to Information Technology (IT) professionals, including large and small businesses companies, government organizations, and major training companies. Main courses were on Designing, Implementing, administering and supporting Windows NT4.0, 2000, 2003; Exchange 5.5 and 2000; Designing Active Directory; TCP/IP based network security; IIS 5.0, ISA Server.