Argus Safety Configuration & Technical Support Engineer

Argus Safety Configuration & Technical SupportAlameda, CAFulltime or Long-term contract Onsite role. Key ResponsibilitiesArgus Safety Configuration & Technical SupportConfigure, maintain, and enhance Oracle Argus Safety and Axway B2Bi Gateway based on business and regulatory requirements.Support Argus Console updates including case processing, workflows, reporting, user/security administration, dictionaries, and system configuration.Perform configuration changes related to products, studies, licenses, reporting rules, workflows, code lists, user groups, and other Argus components.Troubleshoot application, database, interface, and performance issues.Support upgrades, patches, migrations, and environment refresh activities.Perform technical impact assessments for application and configuration changes.Perform monitoring of the Argus Safety and Axway B2Bi systems.Knowledge of whole Argus Safety infrastructure, from Argus servers to Argus front-end application.Integration & Data ManagementDesign, develop, support, and troubleshoot integrations between Argus and upstream/downstream systems.Support data exchange using E2B(R2)/E2B(R3), XML, web services, database interfaces, and file-based integrations.Support integrations with regulatory authorities, safety gateways, clinical systems, medical information systems, data warehouses, and other enterprise applications.Develop and maintain data migration and transformation processes for safety data.Perform data analysis, reconciliation, and troubleshooting using SQL and database tools.Knowledge of PL/SQL and SQL Advanced language.Database & Technical DevelopmentDevelop and troubleshoot complex Oracle SQL and PL/SQL queries, procedures, packages, and scripts.Analyze Argus database structures and application data to investigate production issues.Develop utilities, scripts, or automation to improve operational efficiency where appropriate.Support database-related activities in coordination with infrastructure and DBA teams.Assist with performance analysis and optimization.ReportingSupport Argus reporting requirements, including operational, compliance, and regulatory reports.Develop or maintain custom reports and data extracts using SQL and applicable reporting technologies.Support aggregate and expedited reporting processes from a technical perspective.Troubleshoot reporting discrepancies and perform data reconciliation.Validation & Regulatory ComplianceEnsure technical changes comply with applicable GxP, Computer System Validation (CSV), 21 CFR Part 11, and data integrity requirements.Participate in requirements gathering, technical design, configuration specifications, risk assessments, testing, and validation activities.Prepare and review technical documentation, including configuration specifications, design documents, test scripts, deployment plans, and implementation records.Support audit and inspection readiness activities related to Argus Safety.Follow established SDLC, change control, incident management, and release management processes.Production SupportProvide Level 2/Level 3 technical support for Argus Safety.Investigate production incidents and perform root cause analysis.Coordinate with business users, infrastructure teams, DBAs, Oracle Support, and other vendors to resolve complex issues.Support planned releases and production deployments.Monitor interfaces, scheduled jobs, reporting processes, and other critical Argus components.Participate in production support/on-call activities when required.Required QualificationsBachelor’s degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field.5+ years of IT experience, within pharmaceutical, biotechnology, or life sciences organizations.3+ years of hands-on Oracle Argus Safety technical experience.Strong understanding of Argus Safety architecture, configuration, database structures, and integrations.Strong Oracle SQL and PL/SQL skills.Experience troubleshooting Argus application, database, interface, and reporting issues.Experience with safety system integrations and data migration.Understanding of E2B(R2)/E2B(R3) safety reporting standards and ICSR data exchange.Experience working in validated/GxP environments.Knowledge of 21 CFR Part 11, CSV, SDLC, change control, and data integrity principles.Strong analytical and problem-solving skills.Ability to communicate effectively with technical teams, business users, and Pharmacovigilance stakeholders.Preferred QualificationsExperience with recent versions of Oracle Argus Safety.Experience with Argus upgrades and migrations.Experience with Argus Interchange / E2B Gateway configuration and troubleshooting.Experience integrating Argus with clinical, regulatory, medical information, or enterprise data platforms.Experience with REST/SOAP APIs, XML, JSON, and web services.Experience with cloud environments such as AWS, Azure, or Oracle Cloud.Experience with automation, scripting, and CI/CD practices.Familiarity with pharmacovigilance processes including ICSR processing, expedited reporting, MedDRA/WHO Drug coding, case workflows, and regulatory submissions.Experience supporting validated systems in global pharmaceutical environments.