Professional Summary

Technology Professional with over 14 years of experience in project lifecycle from conception to completion in Information Technology, Pharmaceutical and Life Sciences domains.

Managed complete project life cycles including Gathering and Synthesizing Requirements, Technology planning, Scoping out deliverables, Roll Outs, Upgrades, Testing, Validation and Ongoing Operational support.

Analyze and suggest Vendor capabilities like product strength, comparison of different tools based on the cross functional team requirements.

Analyze Vendor quality evaluations like delivery, customer service, quality and pricing.

Hands on experience of legal documentation like SOW, RFP, Licensing with different Regulatory, Clinical and drug safety systems.

Supporting projects for global pharmaceutical/biotech clients involving Regulatory Affairs (Register) and Drug Safety System (ARISg suite, Argus), agXchange IRT, EDC systems and Finance applications.

Delivered project deliverables such as functional requirement specifications, design documents and validation summary reports.

Developed business intelligence dashboards, KPIs for research endeavors, CROs and Affiliates.

Extensive knowledge in designing, delivering and supporting GxP systems: Developed and executed IQ/OQ/PQ Protocols as per the 21 CFR Part 11 compliance. Extensive knowledge of Computer System IDMP Solutions, Validation, Quality Assurance, ICH, PV Quality and Compliance, CDISC, SDT, CDASH

Strong Domain Expertise in Life Sciences, Drug Safety thesauri, such as MedDRA, WHO Drug Dictionary and safety and clinical industry guidelines.

Technical Skills

Area of Expertise

Life Sciences / Pharmaceutical Systems, Vendor Evaluation and Audit, Computer System Validation, Drug Safety System, Clinical Operation, Regulatory Affairs, Quality Assurance, IQ/OQ/PQ Protocols, Project Management, Business Analysis, Business Intelligence, Safety and clinical Data Management

Application Servers

Weblogic, Websphere, JBoss, SAP Netweaver

Programming Language

C, PL/SQL, SAS,Python

Other Tools

SQL Developer, Toad, Pl/Sql Developer, Visio, Microsoft Project Planner, WinSCP, Filezilla, Livelink, QuickBase, eTMF, Business Objects, Tableau, Spotfire

Safety Applications

ARGUS, ARISg/j 6.x (ESM), Arisg/j 5.x, agXchange 6.x(IRT/OST), agXchange 5.x and Universal Connector, RAVE EDC

Education

Bachelor of Engineering, Visweswariah Technological University Belgaum

Professional Experience

Gilead Sciences, Foster City, CA Jul2017 – Present

Role: Business Analyst

Develop and deliver requirements specification and business specification requirements for IT Quality management systems as per the 21 CFR Part 11 compliance and PV Quality and Compliance.

Develop User requirements. Act as a System Analyst for the project deliverables that supports different cross functional projects, including functional requirements, design documents, UAT plans, and other deliverables for different configuration and configuration.

Support vendor assessment process, plan and facilitate vendor demos

Owned the change control for any/all changes to requirements involving business configuration, deployment architecture.

Genentech, South San Francisco, CA Jun2014 – May2017

Role: Senior Business Analyst

Develop and deliver requirements specification and business specification requirements for IT Quality management systems as per the 21 CFR Part 11 compliance and PV Quality and Compliance.

Involved in developing Project plans, Budget plan, Risk Mitigation Plan, Status Dashboard, Timeline visuals for different PVIS and Data management projects.

Developed customized test scripts, quality management documents like SOPs, IQ and OQ for the project.

Act as a System Analyst for the project deliverables that supports different cross functional projects, including functional requirements, design documents, UAT plans, and other deliverables for different configuration and configuration.

Worked with the following systems: TrackWise, OpenText Livelink / Content Server, and / or other Enterprise Quality Management and Document Management systems

Provided data analysis from the pharmacovigilance and literature databases for regulatory reporting and signal detection across cross functional teams.

Provided functional leadership during upgrades and implementation with various cross functional teams.

Represented Data Management team in leading a cross-functional team in gathering requirements, analyzing deliverables DSUR, PBRER for Signal detection & Analysis.

Designed and delivered solutions for data acquisition, data audit, and business process design, cataloging and generating points for safety data.

Assembled and led teams focused on improving key Data management processes e.g., UAT, database amendments, query management, process study start-up, conduct, and close-out.

ArisGlobal, San Ramon, CA Mar 2013 - Jun 2014

Role: Principal Consultant / Project Manager

Led a team of 8 in the deployment and upgrade of ARISg 6.6x / ARIS6.5.7x version Total Safety Suite at Genentech / Roche, EISAI Inc. Developed and managed plans for deployment, upgrade, Proof-of-concept and drafted the technical architecture document for the deployment across multi-dimensional teams.

Created a comprehensive Project Requirements Document working with cross-functional teams like Data migration team, Business process and Quality, synthesized requirements into detailed Technical specifications.

Involved in Vendor assessment and selected right tool for the cross functional teams, and involved in vendor audit.

Developed customized test scripts and IQ/OQ/PQ for the project as per the 21 CFR Part 11 compliance in support of system and User Acceptance Testing (UAT).

Owned the change control for any/all changes to requirements involving business configuration, deployment architecture.

Mentored, supported and guided Genentech/Roche staff on company products, processes and reports

ArisGlobal Professional Services Group, San Ramon, CA Dec 2006 - Feb 2013

Role: Senior Consultant

Led the technology team in Deployment, Configuration and Implementation of Total Safety Suite (ARISg and agXchange IRT) at various clients including Genentech/Roche, Baxter, EISAI, Arena Pharmaceuticals, Lexicon Pharmaceuticals, Pfizer Inc.

Defined the technical architecture, implementation methodology and codified business rules specific to the customer needs working closely with internal and external stakeholders.

Developed customized test scripts and IQ/OQ/PQ for the project as per the 21 CFR Part 11 compliance.

Provided maintenance updates to all the critical issues after GO-LIVE by providing the hotfixes.

Designed and delivered custom business intelligence dashboards/reports for the customers like Pfizer and Takeda Pharmaceuticals to address operational and research needs.

Guided internal/external stakeholders through implementation, conducted workshops, helped define the standards based business processes and standard operating procedures.

Past Professional Experience

Software Engineer, SPAN System Corporation, Bengaluru, India

I.T. Engineer, CMC Ltd. (A TCS Company), Bengaluru, India

Software Engineer, Sparkle Technology, Bengaluru, India

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