CVP is seeking a highly talented Software Systems Engineer to assist in the operation and maintenance of the FAERS I COTS pharmacovigilance tool. He/She will support workflow setup, configuration, edit check development, COTS administration, and patch deployments.
- Support workflow setup, configuration, and edit check development
- Support COTS administration and patch deployments
- Provide industry support and troubleshoot post production issues
- Support MedDRA dictionary upgrades
- Experience in the following software packages: SQL, PL/SQL, Oracle database 11g and above, Oracle JDK, Oracle Single Sign-On, and ERwin Collaboration tools
- Demonstrated experience with International Council For Harmonization Of Technical Requirements For Pharmaceuticals For Human Use (ICH) E2B (E2B is the international standard for transmitting medicine adverse event reports) R2 and Health Level Seven International (HL7) R3 messages
- Understanding of the publically available FDA Quarterly Data Extract (QDE) policies, processes, and procedures
- Experience providing industry support and troubleshooting post production issues
- Experience with log analyses, firewall troubleshooting, configuration patch deployments, troubleshooting subsystems (FLARe & Internet Stats), data call support (# of accounts, server specs, RAM and CPU performance), OS patches, and VDDs
- Knowledge and familiarity with cloud computing, hosting and publishing application environments, and databases on the cloud
- Experience in implementing COTS Pharmacovigilance software tools
- Experience in implementing ICH E2B R3 data standards and converting ICH E2B (R2) messages to ICH R2B (R3), keeping in mind the backward and forward compatibility and data migration issues
Customer Value Partners, Inc. is a VEVRAA Federal Contractor and an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability. Customer Value Partners seeks to provide employment opportunities for protected veterans and individuals with disabilities.