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Jessica Claire
Montgomery Street, San Francisco, CA 94105
Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Summary
Multidimensional IS leader with vast experience in performing business analysis, strategic planning and process improvements. A dedicated professional that understands the significance of new technologies to a growing organization and delivers innovative solutions by collaborating effectively with clients. Core Qualifications Strong domain expertise in Pharmacovigilance Capable of managing multiple projects/teams and working knowledge in Clinical and Regulatory simultaneously while remaining mindful of all project Affairs deadlines and priorities Experience in implementing business critical GxP Excellent client-facing and vendor management validated applications, leading infrastructure skills deployment and performing system analysis Experienced Senior Oracle DBA responsible for Results-oriented individual with learning agility and managing enterprise databases focused on delivering value; excellent team player Experienced in leading directly/indirectly high performing with proven track record of consistently delivering teams of over 30 people solutions to the business in a climate of ambiguity and dynamic change
Skills
  • Automate, Upgrades
  • Business strategies, Validation
  • Change management
  • Client
  • Data integration
  • Data migration
  • Database Administration
  • DBA
  • Databases
  • Database
  • Delivery
  • Disaster recovery
  • Financials
  • Forecasting
  • Functional
  • Funds
  • Internal audits
  • Regulatory compliance
  • LIMS
  • Managing
  • Mergers and Acquisitions
  • MS SQL Server 6.5
  • 2000
  • Migration
  • Oracle
  • Oracle 8i
  • PL/SQL
  • Performance analysis
  • Quality
  • RDBMS
  • Reporting
  • Safety 5.1.X
  • Safety
  • Scripts
  • MS SQL Server
  • SQL
  • Strategy
  • Sybase
  • System Analysis
  • Transact SQL
Experience
02/2011 to Current
Sr. Manager Information Systems/Principal IS Business Analyst Amgen Inc City, STATE,
  • Achieved $15M in cost savings by deploying a solution (JMP Clinical) to automate safety narratives from clinical data used in regulatory filings.
  • This was accomplished by reducing manual rewrites, QC steps, and cost per unit in creating safety narratives Key contributor towards successful delivery of Argus platform/upgrades which resulted in increasing regulatory compliance and efficiencies for management of adverse events Implemented various innovative custom solutions (e.g.
  • Safety narrative improvements, in-stream data checks, analysis of similar events) within Argus Safety to advance the existing functionality by gaining operational efficiency, reducing costs (time and resources) and increasing data quality Completed the Identification of Medicinal Product (IDMP) Readiness Assessment for Amgen's product data.
  • Increased companywide understanding of IDMP product data required for regulatory submissions Delivered on Amgen's strategy for Mergers and Acquisitions (M&A) by integrating Safety data for newly acquired companies by providing a global adverse event reporting for safety; this helped maintain regulatory compliance and supported the increasing workload and complexity of global Pharmacovigilance Delivered LIMS application installations as Lead DBA which provided a scalable Sample Analysis and Management System to support Amgen's growing product pipeline, Responsible for all Pharmacovigilance systems and for managing and delivering varied portfolio of service offerings in alignment with business and IS strategy Managed a team of over 30 individuals to support the Safety organization in evaluating and providing solutions to the business focused on Pharmacovigilance Defined and maintained multi-year IS strategy, roadmap and resource plan to support Safety organization with regards to its business strategies and goals Managed portfolio related financials including securing funds, forecasting, resource planning and execution Participated as a subject matter expert for Pharmacovigilance Systems.
  • Contributed as a key member in many cross-functional corporate Amgen initiatives with various stakeholders, service owners, and technical teams from all IS organizations globally impacting Safety organization Provided support during inspections and audits (e.g.
  • FDA, MHRA & Business Partners) for Pharmacovigilance systems Led several M&A initiatives for migration of safety data into a global Pharmacovigilance system.
11/2008 to 02/2011
Specialist IS Business Analyst Amgen Inc City, STATE,
  • Responsible for delivery of IS solutions by managing Safety client service requests, requirements elicitation, process improvements, and system analysis by addressing business and IS functional gaps Responsible and key contributor towards successful implementation for GxP validation of Safety Compliance Program (Argus Safety 5.1.X) to support Pharmacovigilance Operations Responsible for change management process of ongoing releases; performed responsibilities of change owner, provided technical assessments, testing strategies, and managed testing and deployment activities Supported internal audits and regulatory inspections by providing system related information for Argus Safety.
02/2002 to 11/2008
Sr. Database Administrator- Specialist Amgen Inc City, STATE,
  • Managed and supported large and complex databases in Oracle 8i through 10g and MS SQL Server 2000 - 2005 Responsible for maintaining procedures for disaster recovery and carrying out live DR exercises Performed database patching and upgrades Provided impact analysis of new requirements, and assisted in the design of relevant infrastructure as needed Conducted in depth performance analysis of systems and implemented recommendations (such as database tuning) Performed multiple data migrations across various platforms Led DBA portions of project support activity, including deployment management of applications 2.
02/1997 to 04/2002
System Analyst Programmer II/III Amgen Inc City, STATE,
  • Responsible for all aspects of Database Administration including installation, upgrades, patches, tuning, and maintaining Oracle, Sybase and MS SQL Server 6.5 and SQL Anywhere 5.5 Developed PL/SQL and Transact SQL scripts for data integration and reports Performed System Analysis and data migration between different RDBMS and platforms.
Education and Training
Expected in
Bachelor of Arts: Economics
University of Washington - Seattle, WA
GPA:
Activities and Honors

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Resume Overview

School Attended

  • University of Washington

Job Titles Held:

  • Sr. Manager Information Systems/Principal IS Business Analyst
  • Specialist IS Business Analyst
  • Sr. Database Administrator- Specialist
  • System Analyst Programmer II/III

Degrees

  • Bachelor of Arts

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