Technical Consultant
Job Description
THE POSITION:
Technical Consultant plays a crucial role in pharmacovigilance, particularly in the context of the Argus Safety System. The responsibilities of an Argus administrator, as outlined, involve various aspects of configuration, data management, automation, and collaboration with case processing teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
Key Responsibilities:
• Configure, maintain, and optimize Oracle Argus Safety to support pharmacovigilance operations and regulatory reporting requirements.
• Analyze business requirements and implement Argus configurations aligned with regulatory standards and industry best practices.
• Design, develop, and enhance Argus workflows, business rules, and automation solutions to improve operational efficiency.
• Participate in end-to-end pharmacovigilance data migration projects, including data assessment, profiling, mapping, transformation, validation, and reconciliation activities.
• Collaborate with business, safety, and technical teams to define migration requirements and source-to-target mapping specifications.
• Perform data extraction, transformation, validation, and reconciliation activities to ensure accurate and compliant migration of safety data into Argus Safety.
• Develop and execute SQL queries for data analysis, reporting, migration validation, and issue investigation.
• Identify and resolve application, configuration, integration, and data-related issues within the Argus Safety environment.
• Support system integrations between Argus Safety and external applications using web services and related technologies.
• Develop, customize, and maintain reports and dashboards using Oracle BI Publisher (BIP) to support operational and regulatory reporting needs.
• Participate in testing activities, including system integration testing (SIT), user acceptance testing (UAT), and migration validation testing.
• Ensure system configurations, migrated data, and business processes comply with global pharmacovigilance regulations, including FDA, EMA, and other applicable requirements.
• Support validation documentation and compliance activities for audits, inspections, system upgrades, and regulatory reviews.
• Collaborate with Oracle Support and internal stakeholders for incident management, patch deployments, and system enhancements.
• Provide end-user support, training, and documentation to promote effective system utilization and knowledge sharing.
• Monitor regulatory updates, Argus product enhancements, and industry trends to recommend continuous process and system improvements.
• Perform other duties and responsibilities as assigned.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.
Requirements
Department: Clinical & Medical
Function: Research
Experience Level: Associate