EDWARD KAPLUN

*** ********* **

Ivyland, PA ***74

Email: ac2aea@r.postjobfree.com

Ph #: 908-***-****

SUMMARY Technical Lead and Lead Analyst IT professional with over 16 years’ experience in Pharmaceutical industry particularly in the field of Pharmacovigilance with expertise in data processing, migration and management of Drug Safety, Adverse Events Data collection and reporting, and Risk Management systems (Oracle ARGUS, Oracle AERS, E-TRACE, ARISg, Thesaurus Management System (TMS)) for reporting and evaluating suspected adverse reactions during clinical trials and post marketing authorizations of medicinal products. Possess strong in-depth knowledge of E2B Electronic Data Submission process, aggregate reporting, and Adverse Reactions case processing workflow lifecycle. Experienced in AE data migration between different AE reporting systems using manual and automated processes. Strong hands on development skills in Oracle, PL/SQL and XML. Extensive knowledge in MedDRA dictionary structure and semi-annual versioning update process. Experience includes strong understanding of FDA’s Good Documentation and Quality Assurance Practices, GxP and 21 CFR Part 11 requirements for validated systems. Strong analytical and problem-solving skills. Developed a reputation of being a dedicated and resourceful team player with tenacious work ethic.

TECHNICAL SKILLS ARGUS, E-TRACE, Oracle AERS, ARISg, Oracle PL/SQL, SQL_Server, XML, TruMigrate, TruCompare, TruConsole, Thesaurus Management System (TMS) and TMS Light Browser, MedDRA, REMEDY 7 Incident and Change Management system, GNOSIS document management system, Oracle Forms/Reports, MS Office, MS Project, MS Access, SQL Developer, SQL Navigator, TOAD for Oracle

EXPERIENCE

April 2013 to Valiance Partners, Bernardsville, NJ

Current

Lead Migration Specialist for migration, verification and validation activities for the legacy adverse events reporting systems.

Lead the development of TruConsole and TruCompare configurations and scripts to migrate E-TRACE and ARISg AE reaction safety data to ARGUS database for two major pharmaceutical companies. Conducted number of dry runs, quality control and production data migration working in close contact with clients DB administration, subject matter experts and business representatives.

Responsible for the management of migration and testing of Actavis AERS Safety cases to ARGUS safety database including MEDWATCH, CIOMS, and E2B reports files.

Implemented the data migration from AERS 4.6 source system to ARGUS 7.0 target system. Responsibilities included migration strategy, data mapping, development of migration specification document, creating TRUmigrate migration configurations. Utilized TRUCompare methodology to validate the accuracy of the migrated data.

Responsible for the migration scoping and planning for Spectrum Allos and Valeant safety databases from AERS 4.6 to ARGUS 5.0 system. Responsibilities included identification and mapping of AERS fields to corresponding ARGUS fields, creating the value mapping specification to migrate values according to both systems configuration codes. Created and tested TRUmigrate configurations and executed QA verification scripts.

Managed the process and validation of Talon ARGUS 6.0 database migration to Spectrum ARGUS 5.0 system. Created migrations specification, configuration specification and validation strategy working in close contact with the client and database management.

December 2011 to Pfizer Inc., Bridgewater, NJ via HCL America

March 2013 Safety Data Migration Technical Team Lead

Project Leader on multiple projects regulated by change control process in ARGUS validated environment for customizing and updating ARGUS Safety application according to regulatory compliance rules and regulations adhering to GxP and 21 CFR Part 11. Change controls requested by the business included on boarding of new license parties for E2B reports exchange, products divestment, implementation of auto_accept functionality for initial ICSR reports and fixing application defects utilizing solutions provided by the vendor (Oracle).

E2B Team Lead on E2B process management and production support that included problems evaluation and resolution regarding E2B XML reports sent and received by Pfizer to license parties and health authorities and issues with MDN and ACK files and Cyclone connectivity to partners’ gateway systems.

Led and coordinated hands on development and maintenance for ARGUS Safety application and specifically for E2B DTD elements mapping to different license partners and health authorities using Oracle, PL/SQL and XML.

Managed development, QA testing and implementation phases of the life cycle of change control process.

Worked with the business partners and regulatory authorities personal to ensure that all business, regulatory compliance, and functional requirements are completely implemented in each project.

Managed specific requests from individual License Parties during on boarding process to implement these parties successful configuration in the ARGUS system to enable E2B XML reports export/import exchange between Pfizer and License Parties.

Managed problems evaluation and resolution process for many E2B XML reports processing issues requested by individual health authorities from around the world, EMA and FDA, business management personal and ARGUS end users.

Resolved regulatory compliance related problems with AE reports submissions related to the front and the back end issues in ARGUS application addressing these problems internally within IT department and with the vendor via Service Requests.

October 2006 to Merck/Schering-Plough, Springfield, NJ

December 2011 Lead Data Migration Analyst

Provided technical leadership for AERS application development, maintenance, and production support and configuration changes in a GxP and 21 CFR Part 11 validated environment using skills in ARES, Oracle, PL/SQL, and XML. Activities included:

Thesaurus Management System (TMS) product repository updates with new Company Products, RGNs and Synonyms.

Daily monitoring and supporting regulatory submissions process that included MedWatch, CIOMS, Periodic and E2B submissions to FDA and European Health Authorities. E2B submissions monitoring and troubleshooting included communication with AGWAY gateway team and extensive querying of Oracle database for MDN and acknowledgement (ACK) files.

Global Maintenance of regulatory agencies and associated reportability rules.

E2B Receivers and Sender configuration in Global Maintenance and in AGWAY system.

Products Approvals management for company products and licensing associated with regulatory agencies around the world.

Led daily ARES application development, maintenance and production support by working on and resolving issues reported by end users including network connectivity related issues, system interface and underlying database related issues, processes validation and configuration changes in compliance with Technical Support Manual (TSM) for the application.

Responsible for Portal and Report servers administration and sustainability of AERS application and all its sub-components.

Conducted unit and regression testing during implementation of new application versions and vendor’s patches installation.

IT subject matter expert in resolving compliance related issues with regulatory submissions. Investigated and wrote Corrective Action Preventive Action (CAPA’s) for multiple compliance related issues with regulatory submissions.

Managed E2B expansion project for implementation and configuration E2B reporting system within AERS application for 32 Health Authorities in the European region. Coordinated and set up agencies and reportability rules in the system’s Global Maintenance application in compliance with EMEA and individual agencies regulations.

Supervised MedDRA Dictionary version update every six months as directed by MedDRA Maintenance and Support Services Organization (MSSO). Received new MedDRA dictionary version from MSSO and uploaded new terms using SQL Loader on to AERS Portal server. Using Oracle procedures and UNIX scripts, implemented new version in AERS database. Provided critical MedDRA update impact analysis to the Business community.

Gathered requirements and implemented multiple compliance and metric reports used on a daily basis in streamlining the business process to avoid late submissions to health authorities.

Conducted training sessions with business users discussing various functionalities within Oracle AERS, including Reporting, Submissions, Aggregate reporting and expedited ICSR Reporting.

Partnered daily with the application vendor (Oracle) development team in analyzing production issues with the Oracle AERS application. Initiated service requests with Oracle and worked in coordination with developers on resolutions.

Provided on site Oracle developers with assistance in resolving high priority issues impacting the client community. Participated in the testing and implementation of variety of fixes (patches) and new application releases provided by Oracle or implemented by the GIT development team.

Collected and analyzed business requirements and developed system configuration (SCS) and system design specifications (SDS).

Served as IT analyst in the Merck- Schering Plough Global Safety Integration project by gathering local regulatory requirements for case intake, case processing and reporting for approx. 120 local countries of operations. Defined the scope and estimates of data migration from legacy Merck and Schering-Plough systems into the new Oracle ARGUS Safety database.

Analyzed E2B (R3) standard for the latest ICH Implementation Guide for compatibility testing.

Recognized in Merck’s Shining Performance Reward & Recognition Program for excellent performance and dedication to the company business.

April 2005 to Schering-Plough, Springfield, NJ via Robert Half Technology, Woodbridge, NJ

October 2006 Senior Research Information Services (RIS) Developer and Quality Control Specialist, Consultant.

Application maintenance and developer for CAVIAR adverse reaction reporting and data processing system which collected adverse reaction data from clinical trials and post marketing authorized products reported by clinical investigators and medical practitioners from around the world.

Maintained system’s reporting system that generated ICSR reports for submission to FDA and European health authorities.

Maintained CAVIAR Oracle database back end and associated batch program that processed adverse events data collected from US and European countries on a daily bases.

Guided production support and maintenance of the global clinical dictionary system MedDRA by troubleshooting issues reported by the end-users of dsNavigator LAN site.

Lead production of global dsGateway e-mail system used by clinical investigators to submit adverse reaction events to data processing centers around the globe.

Developed documentation for testing phase of CAVIAR system migration to the new release that enabled the application to collect additional elements of Adverse Events data to adopt European health authority (EMEA E2B) standards and requirements.

Created Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols for new CAVIAR release.

Supported process of testing new GPV CARES Adverse Reaction Reporting System, in order to replace CAVIAR system, by providing the system testing and validation team with ad-hoc queries and reports from CAVIAR system.

January 1999 to Johnson & Johnson, Raritan, NJ via First Consulting Group, Somerset, NJ

April 2005 Senior Software Development Specialist, Consultant, Pharmaceutical Research Institute

Technical lead for Global Data Loading (GDLS) system, which loaded and validated electronically submitted data from central clinical laboratories. Development was performed using VB6, Oracle 8i database with PL/SQL, and Seagate Crystal Reports. Provided technical analysis of the system in accordance with client specification and logical procedures to validate patient data and results of clinical studies. Evaluated clients’ network configuration in order to implement client-server configuration of GDLS system.

Worked on Recorder clinical data information system migration from Oracle 7.3 to Oracle 8i database. Developed technical requirements for NT Cytrix server configuration to provide client with Cytrix service. Developed source code change and testing documentation that was utilized in development and test environments. Assisted in developing requirements and implementation of Oracle 8i client SMS package. Monitored and supported migration of the system into production.

Participated in development and release into production a maintenance release of an application that used approved by FDA clinical dictionaries to code adverse reaction events. The project involved the full development cycle. Development was performed using VB6, Oracle 7.3database with SQL and PL/SQL. Responsibilities included developing GUI code in VB environment and Oracle stored procedures, development of Installation/Operation Qualifications and Change Control documentation.

Developer for Global Biometrics and Reporting System, which automated a number of processes in clinical studies from randomization schedules to validation of clinical trials results.

Developed source code for Auto Batch process that automatically coded verbatim terms from a clinical drug study program.

Developed code for Interactive process that initiated via a desktop icon to allow the user to manually code verbatim terms for a selected program and protocol.

Received Outstanding Performance certificate in recognition of dedication and commitment in making the project a success.

Responsibilities included working with Network Computer Services (NCS) team to create and maintain users’ network accounts, level of security access to different applications and services.

July 1993 to Automated Waste Equipment Co, Trenton, NJ

January 1999 Programmer/Analyst

Developed and maintained applications for ordering, invoicing, shipping and receiving.

Designed GUI systems with reporting functionality VB5/6, Oracle database and Crystal Reports.

Developed stand-alone components and class modules that were utilized for different applications.

Provided client production support and applications maintenance remotely and on the client site.

EDUCATION College of Civil Engineering, St. Petersburg, Russia

B.S. in Mechanical Engineering

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