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 and working knowledge in Clinical and Regulatory Affairs
Experience in implementing business critical GxP validated applications, leading infrastructure deployment and performing system analysis Results-oriented individual with learning agility and focused on delivering value; excellent team player with proven track record of consistently delivering solutions to the business in a climate of ambiguity and dynamic change
Capable of managing multiple projects/teams simultaneously while remaining mindful of all project deadlines and priorities
Excellent client-facing and vendor management
skills
Experienced Senior Oracle DBA responsible for managing enterprise databases
Experienced in leading directly/indirectly high performing teams of over 30 people
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
Education
University of WashingtonSeattle, WAExpected in ā āBachelor of Arts:Economics - GPA:
Work History
Amgen Inc - Sr. Manager Information Systems/Principal IS Business Analyst City, STATE, 03/2011 - Current
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.
Amgen Inc - Specialist IS Business Analyst City, STATE, 12/2008 - 03/2011
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.
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.
Amgen Inc - System Analyst Programmer II/III City, STATE, 03/1997 - 05/2002
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.
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Resume Overview
School Attended
University of Washington
Job Titles Held:
Sr. Manager Information Systems/Principal IS Business Analyst