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Sr. Safety System Specialist Resume

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NJ

PROFESSIONAL SUMMARY:

  • Working as System analyst - Business analyst - Data analyst - Integration analyst
  • 6+ years working on Oracle DB, Argus Safety DB, Clinical DB(CTMS), TOAD, MS SQL server, Oracle Seibel CRM, IBM Cognos analytics, Tableau analytics, HP QC, SharePoint, Visio, XML, MS office, Excel, VBA, PowerPoint, C#, .Net, ETL
  • 8+ years working experience in Pharma/Healthcare industries. Leading resource deliver global scale projects. Managing data qualities / users / venders / schedules
  • Experience in design / develop / verify the data solutions (drug safety, clinical trial, sales), - Delivered validation / analysis / compliance / report / migration / integration / QAQC works in global scale
  • Hold BS, MS, PhD degrees, continue professional training every year, PE,LP licenses,

WORKING EXPERIENCE:

Sr. Safety System Specialist

Confidential, NJ

Responsibilities:

  • Working on clinical trial/drug safety systems in Global pharmacovigilance group to manage the study, data activity, analysis, financial, reports, product, market/sales on Argus Safty DB, and reporting tools.
  • Running SQLs, excel tools, design the strategic IT roadmap and Operation Automation capabilities
  • Consulting and Review Argus configurations, data quality, collect-summary the new function design requirements for customization
  • Consulting and review for newer version MedDRA updates in Argus case data.

Sr. Safety System Specialist

Confidential, NJ

Responsibilities:

  • Working in Global pharmacovigilance systems group for data managing, reporting, analysis, compliance drug safety, clinical trials, products, and sales, marketing operations.
  • Produced large volume aggregate PSURs, DSURs , COIMS, MedWatch, Safety Topic Review reports to Health authorities.
  • Provided data search, analysis, Excel tools, pivot tables, case data report, investigations, safety notifications, compliance, KPIs, statistics, demographics, audit documents. Experienced on IT projects, GxP, MedDRA, SDLC, Validation, requirements.
  • Design/developed the solutions of drug safety/clinic trail database searches, Reporting, Compliance tools, and workflows. Managed project deliverables /knowledge portals/ training / QA-QC / schedule / user expectations / requirements.
  • Increased productivity by work across both business and IT communities with Medical, Clinical, Compliant, Processing, Reporting, Regulatory / Audit teams, and IT teams globally.
  • Develop the necessary documentation for IT and bus. projects (statement of work, business requirements, use cases, functional specifications, systems & end-user documentation).

Sr. Business Data Analyst

Confidential, NJ

Responsibilities:

  • Reporting to Business owners for developing migration-integration solutions to integrate clinical data from legacy systems to a centralized Oracle Siebel Clinical platform.
  • Integrated the clinical data management systems by customize / configure / code Oracle DB, MS SQL server DB, MS Access DB, PL/SQL, TOAD, SQLPlus, C#, .NET, VBA, EIM, FileZila, Oracle Siebel Tool, SAP BO BI tools, Excel Macros, VBA, Tibco Spofire, HP QC, MS SharePoint, DocMall, and other data tool/systems.
  • Delivered a clinical data collection application and clinical data analysis system on groups of iPads. Identify and resolve issues for clinical data protocol, visit, country, site, subject, account, contact, and other major data entities with clinical trials
  • Achieved organization awards from delivering complex migration-integration project

Sr. Business Analyst Analyst

Confidential, NJ

Responsibilities:

  • Assisting business owner developing migration/integration/QA solutions to migrate clinical and safety case data from multi-sources worldwide to an integrated Oracle Argus Safety platforms.
  • Lead a QA team to perform risk assessments and develop test plans for 3 global scale data migration / integration projects with millions clinical and drug safety case data.
  • Increased The system integrity, quality, and productivity
  • Produced 500+ test cases for system testing.
  • Delivered solutions for system and data analysis / Design / transformation / validation, Established system environment by grouping TOAD, HP QC, SAP Business Object report, SharePoint, Visio, XML, Excel, VBA Macros, MS Access, and other vender supported programming/testing tools.
  • Achieved project awards from company and R&D organizations.

Sr. Data Specialist

Confidential, NJ

Responsibilities:

  • Working with business owners of third party venders developing integration solutions to migrate legacy clinical data to a centralized Oracle Clinical platform.
  • Produced Clinical trials data / Drug safety data migration logics, rules, codes, and process. Provide documentation on the internal controls related to systems, operating environment, application and security.
  • Lead a team for Design and develop migration staging DB, cross reference, mappings, transforms, and exception logs. Develop the delivery schedules, and risk assessments.
  • Delivered migration-integration projects on schedule with high quality
  • Achieved high recognitions from company and the delivered clinical trail system expend again to Confidential after SP merged to Confidential

Sr. Business/System Analyst

Confidential, NY

Responsibilities:

  • Responsible for Oracle CRM configuration, admin, scripting, Workflows, Business Services, security, mapping and EIM loading data. Using Oracle/MS/IBM Databases, Siebel, iAvenue, XML, VBA, SQL, Java, web service, MS Office Suits, SSIS, Blackberry, LDAP, MQ Series, TOAD, QC, IBM Cognos, and other data processing, analytical, security, delivery, reporting, and supporting tools.
  • Integrate institutional sales, marketing, financial, product, and customer data to/from 10+ applications which build on Mainframe, UNIX, Windows platforms, DB2, Oracle10x, SQL Server 2000, 2005, and Domino DBs. Programmed VB COM, MQ messaging, XML, SQL, web service, scripting for these integration projects. implemented over 60 MS SQL, SSIS/DTS automated data process packages, automated SSIS packages transfer multi millions data traffic real time.
  • Lead to design, implement, deploy, and support Confidential Institutional Fix Income and Pension Management application on iAvenue & MSSQL Server 2000, 2005 platforms. The applications Integrates institutional sales, marketing, financial, product, and customer data to/from 18+ data sources. Implementation using VB, VBA, SQL, SSIS packages, stored procedures, scripting, XML, on Mainframe, UNIX, Centric, and Window servers.

Business Analyst Consultant

Confidential, NJ

Responsibilities:

  • Lead to adopt XMLife data standards for Confidential project.
  • Using ACCORD standard to map to COBOL copy book messages in Integrated System Controller (ISC) distributed XML data model environment and data mapping document to integration partners in enterprise.

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