PROFESSIONAL SUMMARY:

• 13+ years of progressive experience in Project Management, System Implementation and Support, Validation, Test Planning and Technical Writing in the pharmaceutical and biotechnology industry.
• More than six years in PVE with extensive experience in Argus Safety System Implementation and Upgrades, Reporting, System Support, Project Management and Validation.
• Extensive experience in implementation, data migration, validation, support and business analysis of Argus Safety, Argus Insight and other PV Solutions in a global, matrixed environment.
• Comprehensive understanding of PV business, Case Processing, Expedited and Periodic Reporting and Argus Safety Data Model with proven expertise in PL/SQL and SQL.
• Proven ability to understand User Requirements and develop appropriate software solutions with hands - on approach.
• Excellent analytical skills with ability to function in a fast paced, team-oriented and continuously changing environment and consistently meet deadlines and budget with a keen attention to details.
• Well versed in Software Development Lifecycle (SDLC) and System Validation Lifecycle (SVLC)
• Implementation assessment of Argus v8.1 (Safety, Insight). Analyzing bugs reported in Argus version 7.0.3.1 fixed in 8.1 and new features.
• Creation and Review of Design Specification, Installation Protocol, Validation Package (IQ, OQ, PQ), SOPs and Change Control documents.
• Working with IT infrastructure team for getting (servers, access, database, backup etc.) for Argus 8.x upgrade.
• Working as Argus Safety database consultant to identify, define and document business needs and objectives, current operational procedures, problems, input and output requirements, and levels of systems access.
• Expertise in writing Functions, Procedures, Packages and Database Triggers using PL/SQL.
• Extensive Knowledge of Case Processing, Workflow, ESM profile, Argus Console and configuring Oracle Argus System in validated environment.
• Excellent command over full life cycle of E2B transmission and debugging Inbound & outbound ESM environment along with E2B Extension hands on experience.
• Complete Design, setup and in-depth knowledge of ICH-ICSR E2B Electronic transmission (e2b via XML/SGML).
• Hands on experience of Integration of ARGUS with Eclipse Coding Tool,DS Navigator, Right Fax, Axway B2Bi and Http.
• Hands-on experience of Installation, validation and upgrade of MedDRA and WHO Drug dictionaries.
• Experienced on Unix and Windows operating environment.
• Good team skills and communication skills.
• Excellent learning curve.
• Thorough understanding on ITIL process (Incident, Problem and Change Management)
• Good understanding of 21CFR Part 11, Computer system Validation.
• Involved in end-to-end life cycle starting from initiating the kick-off meetings, Requirements gathering, handling client approvals, Solution design, Configuration and release planning, coordination with the development & testing team to ensure quality deliverables. Coordinating UAT with the client.

TECHNICAL SKILLS:

Pharmacovigilance Applications: Argus Suite (7.x and 8.x) Axway - Gateway Interchange, B2Bi TMS - Oracle Thesaurus Management System 4.6 ds Navigator and Eclipse Coding Tool Letter Distributing System for Investigator Cognos, OBIEE and SpotFire SDEA - Safety Data Exchange Agreement. Medidata Rave EDC Siebel CTMS and Veeva eTMF Evidex Signal Management Empirica Signal/topics

Databases: Oracle 12c/11g/10g/9i/8.x/7.x Sql Server

Languages & Utilities: SQL, PL/SQL, HTML, XML TOAD, Sql Developer, SQL*Loader, Export, Import CVS, PVCS

ETL Tools: Informatica Oracle Data Integrator

PROFESSIONAL EXPERIENCE:

Confidential, San Francisco CA

Responsibilities:

• Support and manage the proper function, maintenance, and validation of Nektar safety systems (Argus Safety and other supporting systems) and adherence to Nektar policies and applicable global (PV) regulations.
• Support changes to the systems under Nektar change control policy, including configuration changes and system upgrades.
• Lead all change controls and data migration projects for supporting the global Gilead Drug Safety System in various roles as Project Manager, Lead Developer, Business Analyst etc.
• Analyzes the current business environment to detect critical deficiencies and identify improvement opportunities.
• Upgrade/Support routine MedDRA and Who Drug dictionary upgrades.
• Participate in the development and validation of required aggregate safety reports.
• Consults with multiple stakeholders (e.g. the Licensing Partner / Clinical Data Manager / drug safety physician) to construct the system requirements
• Support the validation, implementation and maintenance of data transmission gateways with regulatory authorities and partners.
• Provide timely flow of business intelligence information to users.
• Act as a resource to departmental staff on the use of Argus Safety System.
• Work as a team member to achieve goals by communicating information and project status; collaborating on problem resolution; demonstrating leadership; commitment and dependability; and providing technical expertise.
• Update and maintain a Requirements Traceability Matrix.
• Assist in the development of SOPs for the Argus Safety System.
• Participate in the selection and implementation of additional Drug Safety informatics systems including signal detection and post marketing application, safety data warehouse and reporting systems.
• Assist with internal and external audits of the Argus Safety System. Knowledge, Experience, and Skills
• Subject Matter Expert (SME) for end-to-end PV related activities for Nectars’ trial and clinical data
• Provide an oversight on operational activities to the internal team, and have a strong understanding of study protocol, therapeutic indication, budget, and scope of work for assigned projects.

Environment: Argus Safety 8.2.3, Argus ESM, Axway Synchrony Gateway Interchange (B2Bi 2.3.1)Evidex Signal Management, SQL, PL/SQL, SQL*Loader, Oracle 11g/12c, TOAD

Confidential, Foster City CA

Responsibilities:

• Support and manage the proper function, maintenance and validation of Gilead safety systems (Argus Safety System and other supporting systems) and adherence to Gilead policies and applicable global (PV) regulations.
• Support changes to the systems under Gilead change control policy, including configuration changes and system upgrades.
• Lead all change controls and data migration projects for supporting the global Gilead Drug Safety System in various roles as Project Manager, Lead Developer, Business Analyst etc.
• Provide solution for production issues including existing and new customization updates.
• Upgrade/Support routine MedDRA and Who Drug dictionary upgrades.
• Participate in the development and validation of required aggregate safety reports.
• Contribute to adhoc report specification, development, validation and implementation and maintain required validation documents.
• Support the validation, implementation and maintenance of data transmission gateways with regulatory authorities and partners.
• Provide timely flow of business intelligence information to users.
• Act as a resource to departmental staff on the use of Argus Safety System.
• Work as a team member to achieve goals by communicating information and project status; collaborating on problem resolution; demonstrating leadership; commitment and dependability; and providing technical expertise.
• Act as a departmental resource by researching and consulting with others within or outside of the department to resolve issues within the Argus Safety System.
• Assist in the development of SOPs for the Argus Safety System.
• Participate in the selection and implementation of additional Drug Safety informatics systems including signal detection and surveillance tools, safety data warehouse and reporting systems.
• Key role in Argus 8.x up gradation from Argus 7.x
• Assist with internal and external audits of the Argus Safety System. Knowledge, Experience, and Skills
• Monitor and resolve production issues related to Argus Safety suite.
• Designed and developed PL/SQL scripts as part of configuration changes like new reporting rules, validations checks, placeholders and advance conditions etc.
• Developed new E2B validation or modification of existing import or export logic for electronic submissions
• Implemented and supported Eclipse Coding tool for data and dictionary integrations with Argus’s drugs and events related items
• Automated couple of routine tasks like Ack Correction, Mail notification, Job failures
• Creating and Monitoring DBMS Jobs
• Requirements Gathering/Analysis/Estimation.
• Leading development and Implementation of ongoing enhancements.
• Leading E2B customization enhancements for Japan and US reporting.
• Involved in RFP presentation for upcoming projects.
• Work Plan development and Implementation as per client’s SOP.
• Effort estimation for new changes.
• Managing custom Interfaces with Argus and leading changes as per business needs.
• Configuration management in the system using Configuration Baseline Document.
• Up gradation of Axway Gateway Interchange.
• Liaising with vendors and multiple project teams to achieve project goals.
• Requirement gathering, analysis and implementations in the system.
• Consulting clients in important aspects like Infrastructure, environments and estimates for projects.
• Interface development with Argus Safety.
• Lead change request in the system as per SOP’s.
• Authoring and executing IP, IQ and OQ.
• Setting up E2B electronic reporting from Argus Safety.
• E2B customization to meet regulatory compliance for regulatory agencies like PMDA, EMEA and FDA.
• Leading configuration changes in Argus safety with business.
• Configuring new periodic templates in Argus safety.
• Configuring new Reporting rules, Projects, Family, License and study products in Argus safety by following the work processes.
• Argus Console Configuration including Code list, flexible code list, business configuration, access management and system configuration.
• Periodic and aggregate reports generation from Argus safety.
• Troubleshooting of day-to-day issues
• Debugging of complex technical ESM issues.
• Working with non-e2b Argus Issues like Workflow/Reporting/ AC/Config etc..
• Performing Annual DR Testing.
• Involved in creating Requirement specification, Design Specification, Trace matrix, test cases, executing, reporting bug, Impact analysis etc.
• Performing Safety DB Refresh periodically.
• E2B R2/R3 import/export Customizations.
• Co-ordinate with offshore team to manage Argus Support activities
• Set-up E2B exchange with Health Authorities and License Partners and develop custom E2B Profiles
• Support cross-functional projects with RA and QA
• Perform routine project management activities, status reporting, stakeholder management, and workload and resource distribution.
• Manage RFP’s, create Business Cases, Project Charters and assist in developing PV technology roadmap

Environment: Argus Safety 8.1.2, Insight 8.1.2, LAM, Argus ESM, Axway Synchrony Gateway Interchange (B2Bi 2.3.1), Argus EOSU, Oracle Empirica Signal/topics, SQL, PL/SQL, SQL*Loader, Oracle 11g/12c, TOAD

Confidential

Responsibilities:

• Developed the procedures and functions as per the requirements for the upgrading of TMS application
• Analysis of the specifications provided by the clients.
• Defining New filter dictionary as SMQs
• Loading SMQs into TMS
• Mapping SMQs with Standard MedDRA Dictionary Terms
• Validating Data Load Process into TMS 4.6.1
• Prepared SMQs Up version Script.
• Loading Custom SMQs through Script
• Testing - unit testing & integration testing
• Created RO tables to access other External System
• Created refresh jobs to refresh daily created SMQs
• Handled the exceptions for different kinds of errors
• Involved in developing code with shell scripting.
• Developed code to import and export bulk data from and to the database tables.
• Designed a Disconnected system Integrator Interface
• Prioritize and delegate daily workload for safety database team.
• Maintain up-to-date knowledge of regulatory requirements for safety reporting as it relates to the safety database.
• Manage safety database upgrades and change control processes.
• Serve as main point of contact for vendors and safety database related inquiries.
• Maintain and develop system related Standard Operating Procedures (SOPs) and procedural
• Led the customization activity for ESM back end transmit code changes.
• Working on the ad- hoc request for various issues and latent change.
• Analyzing business requirements and implementing enhancement as per client requirement.
• Key role in Argus 7.x up gradation from Argus6. x.
• Generation of Business-Critical Report on MS SQL Server 2005 for Quality Management Application.
• MedDRA, WHO Drug and J Drug dictionary upgrade.
• Developing Complex SQL queries/ PL/SQL Objects for Adhoc reporting.
• Working with oracle for various issues and problem.
• Server maintenance activity for Quality Management and Drug Safety Application
• Preparing and analyzing the weekly performance report of the product for different global markets and sharing the same with the business management team.
• Support for pre-approved change process (i.e. maintenance of code lists, Reportability rules, etc.) including utilizing of DMR tool (to load information from spreadsheets)
• Engage / Escalate to Shared Services teams and Oracle Support as necessary for incident/problem resolution; “own” incidents until resolved

Environment: Oracle Pharmacy Applications (OC, RDC, ARGUS, TMS and LSH), Oracle 11G, Windows XP, UNIX, SQL*Plus, TOAD, Oracle SQL, PL/SQL Developer, Shell programming

Confidential

Responsibilities:

• Developed the procedures and functions as per the requirements for the upgrading of TMS application
• Analysis of the specifications provided by the clients.
• Dictionary Definition, Repository Maintenance and Oracle Clinical Integration
• Repository Browsing, Verbatim Term Assignments
• QA assurance/Testing
• Performed database testing at various levels. Created Unit Test Documents with screenshots so that the QA can later test them again. Pre-build/Integration/Smoke testing of Argus builds during various Releases and Patch projects.
• MedDRA Dictionary Upgrade every six months
• Monitoring DBMS Jobs
• Designing and Developing Reports using Discoverer 4i/10g.
• Executing CSS Test Scripts as part of 4.5.2 to 4.6 Upgrade
• Testing - unit testing & integration testing
• Converting the specifications into packages and pl/sql procedures, functions.
• Created the unique indexes on tables in order to avoid duplicates
• Involved in developing code with shell scripting.

Environment: Oracle Pharmacy Applications (OC, RDC, ARGUS, TMS and LSH), Oracle 10G, Windows XP, UNIX, SQL*Plus, TOAD, Oracle SQL, PL/SQL Developer, Shell programming

Confidential

Responsibilities:

• Designed and developed RICE components
• Analysis of the specifications provided by the clients.
• Designing and Developing Forms using forms 10g .
• Creating data base procedures, functions and packages based on requirements.
• Database management and performance testing
• Testing - unit testing & integration testing
• Support the application in dev, UAT and Prod environments
• Created the context indexes on tables in order to work context search

Environment: Oracle Retail Applications 13.0 (RMS, RPM, RIB), forms10g, PL/SQL, SQL*Loader, Oracle 10g, TOAD, PL/SQL

Confidential

Responsibilities:

• Designed and developed RICE components
• Worked on developing interfaces between legacy systems and Oracle Applications.
• Developed programs to load PO Receipts files from external systems to APPS modules.
• Design and developed new forms using TEMPLATE.fmb and registering them in oracle applications.
• Developed PL/SQL Packages, procedures and functions for validating the order information received from the legacy system and importing them into Oracle Applications using “Order Import” API, which populates the base tables.
• Worked on customization of Sales Order form (OEXOEORD) to populate an error message if the given item price is less than ‘$.01’, also to populate territory of the given salesperson in the DFF using CUSTOM.pll.

Environment: Oracle Financials (GL, AP, AR, OM, PO) 11.5.10, Oracle forms 6i, Oracle Reports 6i, PL/SQL, SQL*Loader, Oracle 9i, TOAD 8.5, Discoverer.

Confidential

PLSQL Developer - Oracle EBS

Responsibilities:

• Key responsibilities include data conversions, customizations, implementing applications, working with Reports, Forms, customizing workflow processes, creating alerts, implementing some of the administrator responsibilities.
• Designed and Developed Forms 6i and Reports 6i by using Forms Builder and
• Reports Builder.
• Involved in writing the procedures, functions, packages used in developing the reports related to AP, AR etc.
• Performed Auto Lockbox interface to create receipts for the date from feeder system.
• Developed Vendor Conversion Program, to import vendors from the legacy system into Oracle with required validations to avoid creation of duplicate vendors and sites.
• Optimized long running SQL queries.

Environment: Oracle Financials (GL, AP, AR, OM, PO) 11.5.10, Oracle forms 6i, Oracle Reports 6i, PL/SQL, SQL*Loader, Oracle 9i, TOAD 8.5, Discoverer.

Confidential

 Oracle Forms and Reports Developer

Responsibilities:

• Designed and developed various new Forms and Reports using Oracle 6i Forms Builder and Reports Builder.
• Preparing technical documents.
• Customizing Existing Reports
• Installation of Oracle database for new Legacy applications and connecting to various data sources to generate business reports.

Environment: Oracle forms 6i, Oracle Reports 6i, PL/SQL, SQL*Loader, Oracle 9i, TOAD 8.5, Oracle Discoverer.