Technical Consultant

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. Qualifications

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

• Participate in end-to-end pharmacovigilance data migration projects, including data assessment, profiling, mapping, transformation, validation, and reconciliation activities.
• Collaborate with business stakeholders, Pharmacovigilance, Regulatory Affairs, and IT teams to gather migration and reporting requirements.
• Develop and maintain source-to-target mapping documents, data migration specifications, and reconciliation reports.
• Execute data extraction, transformation, cleansing, and validation activities to ensure data quality and integrity throughout the migration lifecycle.
• Perform SQL-based data analysis, data validation, reconciliation, and issue investigation to support migration and reporting activities.
• Identify, analyze, and resolve data discrepancies, mapping issues, and migration defects.
• Support migration testing activities, including System Integration Testing (SIT), User Acceptance Testing (UAT), and post-migration validation.
• Conduct data reconciliation between source and target systems to ensure completeness, accuracy, and compliance of migrated data.
• Design, develop, customize, and maintain Oracle BI Publisher (BIP) reports, line listings, and regulatory outputs based on business requirements.
• Create and optimize complex data models, templates, and report layouts within Oracle BI Publisher.
• Support generation and validation of operational, regulatory, and management reports using BIP and database queries.
• Develop and optimize SQL queries, stored procedures, and scripts to support reporting, migration, and data analysis requirements.
• Collaborate with technical teams to support integrations, data interfaces, and reporting solutions across pharmacovigilance systems.
• Participate in system upgrades, enhancements, and migration projects, ensuring reporting and data validation requirements are met.
• Prepare and maintain migration documentation, validation evidence, test scripts, SOPs, and technical specifications.
• Ensure migrated data and reporting processes comply with pharmacovigilance regulations and organizational data governance standards.
• Provide end-user support and training related to migration deliverables, reporting solutions, and BI Publisher reports.
• Monitor reporting performance and recommend process improvements to enhance efficiency, accuracy, and compliance.
• Stay current with Oracle BI Publisher enhancements, data migration best practices, and emerging pharmacovigilance technologies.
• PREFERRED QUALIFICATIONS:
• Bachelor s degree/Masters Degree in IT Stream
• 3+ years of relevant experience in drug safety IT Systems