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 AnalystAmgen 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 AnalystAmgen 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- SpecialistAmgen 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/IIIAmgen 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:
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Resume Overview
School Attended
University of Washington
Job Titles Held:
Sr. Manager Information Systems/Principal IS Business Analyst
