Oracle Argus Consultant

Job description:

Key Responsibilities

Argus Safety Configuration & Technical Support

• Configure, 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 Management

• Design, 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 Development

• Develop 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.

Reporting

• Support 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 Compliance

• Ensure 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 Support

• Provide 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 Qualifications

• Bachelor’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 Qualifications

• Experience 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.