Meiko Hayashida

Experience

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  Digital Design

  Jan 2000 - Jan 2010

  Business Analyst

  As a Business Analyst for custom ERP application projects: Finalized configuration and customizations requirements, and verified them optimizing expertise and knowledge.• Conducted workshops to gather and finalize user requirements.• Authored UFRS.• Developed applications using VB, MS Office, and Oracle Database.• Authored and executed OQ/PQ scripts.• Participated in Hypercare.

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  Kula Sushi USA, Inc.

  Jan 2011 - Jan 2012

  Assistant Store Manager

  Assistant Store Manager• Managed people and operated the store.

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  System 7, Inc

  Jan 2012 - Jan 2013

  English-Japanese Bilingual Technical Assistant

  English-Japanese Bilingual Technical Assistant• Designed Excel macros for data analysis purposes for a Japanese car maker R&D Division.

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  RxLogix Corporation

  Jan 2013 - Jan 2015

  Business Analyst

  ** Notable Projects **1. Argus Japan Implementation for a US based Pharmaceutical Company.Approximately one-year Argus global/Japan implementation project. There was no legacy system used by their Japan branch and, therefore, all configuration related to the Japan branch started from scratch. The project involved end user operation guide development and onsite user training in Japan.As Business Analyst for Argus Japan Configuration: Configured Japan specific reporting rules, executed validation and provided training optimizing Japanese language skill, Japanese drug safety regulation knowledge, and Japan specific configuration knowledge.• Authored/dry ran OQ/PQ scripts for configuration and reports for Argus 7.x Implementation.• Configured PMDA reporting rules.• Translated the English user manual into Japanese and authoring instructions on Japan specific functionalities.• Provided onsite training for the users in Japan.2. Argus Operation Support for a top 3 Japan based Pharmaceutical CompanyThe primary objective was to resolve configuration issues existing in the configuration. Provided expertise for new configuration implementation and developed tools outside Argus/Cognos such as excel macros to fill missing functionalities.As Project Manager: Provided on-site solutions and enhancements in a timely manner, analyzing issues. Also supervised and delegated MS team in India that worked on complex technical issues and provided the solutions.• Added/Modified configuration (PLS) as per change requests.• Consulted with the client on the existing configuration, creating the change requests, validating them, and implementing them in the test/production environment.• Developed SQL and Excel macros to cover the functionalities that Argus/Cognos missed.• Created enhancement requirements for a third-party PV analysis software connected to the Argus database. Show less

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  Foresight Group International AG

  Jan 2015 - Jan 2017

  Sr. Consultant

  ** Notable Projects **1. Argus Upgrade for a top 3 Japan based Pharmaceutical Company. The primary objective was to act as a liaison for the workstreams such as configuration, custom reports, business transformation, and validation workstreams for a client.As Project Coordinator: Provided on-site support for configuration, custom reports, business transformation, and validation workstreams to help smooth accurate communication between these functions and the client. Also provided workarounds, inputs, and resolutions in response to being consulted by the client on issues and requests.• Compiled requirements on customizations/custom reports/data transformation for the team to assist finalizing the requirements.• Performed as a single point of contact on the Japanese side during Hypercare, maintaining/tracking issues, looking into the causes, providing the solutions, serving as a liaison between the client and the team.2. Argus Japan Implementation for a US based Pharmaceutical Company.The primary objective was to create training modules and validation scripts.As a Member of the Validation Team and Business Transition Team: Executed validation and provided training modules optimizing Japanese language skill, Japanese drug safety regulation knowledge, and Japan specific configuration knowledge.• Created training modules for Argus Japan users.• Authored/Dry ran configuration validation scripts for Argus J. Show less

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  IQVIA

  Jan 2017 - Jan 2019

  Associate Principal

  ** Notable Projects **1. Argus Upgrade for mid-small scaled Japan based Pharmaceutical CompanyThe primary objectives are to lead a configuration workstream for successful configuration implementation and to provide configuration expertise for the client to determine 8.1.1 configuration and customizations meeting their business requirements and drug safety regulations.As Configuration Lead: Finalized configuration, customizations, and data transformation requirements, and verified them optimizing expertise and knowledge. Also supervised, delegated, and scheduled the workstream’s members for quality deliverables on a timely manner.• Supported SMEs to conduct workshops and follow-up clients to finalize configuration and customization requirements. Also conducted a couple of small workshops and calls with the client.• Provided expertise to finalize requirements on application customizations, E2B R3 customizations, data transformation, etc., and to answer the clients’ questions.• Presented configuration expertise across the other workstreams.• Conducted Conference Room Pilots and attended Hypercare after the system go-live.• Authored and/or edited, and maintained configuration related documents such as User Requirement and Functional Document s (UFRS), Configuration Base Documents (CBD), etc.• Authored/Dry ran configuration validation documents. Show less

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  Sophos IT Services

  Oct 2019 - May 2020

  Principal Safety Practice Japan

  The primary objectives are to explorer business opportunities in Japan, localize company products for Japan and comply them to Japan regulation, add new service lines for Japan, and transfer knowledge on Argus J specific configuration and Japan regulation to team members.• Created Argus G/J user guides and training slides for service offering and internal training purposes.• Attended DIA Japan to introduce the company, company products, and services to Japanese clients.• Visited prospective clients, introduced company service offerings, and explored clients’ needs for sales. • Documented requirements for company PV reporting/analysis product enhancements and Japanese localization.• Trained team members on Argus J specific configuration and Japan regulations. Show less

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  Perspective Pharmacovigilance, Inc.

  Oct 2020 - Feb 2023

  Director of PV Systems
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  Independent CSV Consultant

  Feb 2021 - Jan 2023

  Independent CSV Consultant

  Provide CSV support for SAP and adjacent systems global implementation projects for one of the top 3 medical device companies in Japan.

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  Nextrove, LLC

  Mar 2023 - now

  Director, PV Services