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Job Description
Pharmacovigilance reporting consultant developing validated Argus Safety reports and dashboards. Supporting Parexel’s clinical research and patient-safety solutions through SQL, PL/SQL, and BI tools.
Responsibilities:
- Design, develop, customize, and maintain reports and dashboards for Oracle Argus Safety case management, expedited reporting, case processing, and regulatory submissions
- Write and optimize complex SQL and PL/SQL queries, procedures, and views to extract, transform, and reconcile data from Oracle Argus Safety databases
- Perform unit, functional, and data validation testing to ensure report outputs, calculations, filters, and aggregations are accurate and compliant
- Develop dashboards and visualizations tracking Pharmacovigilance metrics, case volumes, processing timelines, and compliance indicators
- Translate business and Pharmacovigilance requirements into technical specifications, design documents, test scripts, and validation documentation
- Support User Acceptance Testing, report deployment, post-deployment verification, and production issue resolution
- Troubleshoot data discrepancies, report execution failures, and performance issues; tune queries to improve execution time
- Enhance reporting solutions and configure report scheduling and automated distribution
- Support reporting activities during Argus upgrades, application enhancements, and database migrations
- Identify opportunities to automate manual reporting and work with cross-functional teams to resolve Argus Safety data and reporting issues
- Collaborate with business analysts, Pharmacovigilance stakeholders, technical teams, and global client teams
- Follow GxP-aligned, industry-standard processes throughout the reporting lifecycle
Requirements:
- Bachelor’s or master’s degree in computer science, Information Technology, Engineering, or a related discipline
- 4-6 years of experience in IT application development, reporting, BI development, or technical consulting
- Hands-on experience developing and maintaining reports using IBM Cognos Analytics or Report Studio, OBIEE, JReport, Microsoft Power BI, or Oracle Argus Insight, Argus Mart, or Argus Analytics
- Strong knowledge of SQL and PL/SQL, including complex queries, joins, subqueries, functions, and stored procedures
- Experience with Oracle databases and the report development lifecycle, including requirements analysis, design, development, testing, validation, and deployment
- Good understanding of Pharmacovigilance business processes and Oracle Argus Safety database architecture, particularly Individual Case Safety Reports (ICSR)
- Experience working in drug safety, Pharmacovigilance, clinical research, or another regulated environment
- Comfort working with Oracle databases, Oracle Argus Safety data, and structured report validation processes
- Strong communication, organization, and problem-solving skills
- Exposure to aggregate and periodic safety reporting, such as PSUR, PBRER, and DSUR
- Experience developing reports for adverse event case management, expedited regulatory reporting, or safety metrics and management dashboards
- Familiarity with Cognos Framework Manager, OBIEE Repository (RPD), BI Publisher, Power BI DAX, and Power Query
- Knowledge of ETL processes, data warehousing, and data modeling
- Understanding of E2B (R2 and R3), Axway EDI Gateway, and Argus integrations
- Exposure to Python, reporting automation, and data analytics
- Knowledge of Snowflake and cloud-based reporting platforms
- Exposure to GxP, 21 CFR Part 11, Computer System Validation (CSV), and software validation practices
Benefits:
- Flexible work arrangements
- Growth opportunities
- Continuous learning opportunities
- Diverse teams
- Opportunities to deepen expertise and expand skills across Pharmacovigilance and clinical research
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