Consultant

This is a fully remote position, open to applicants in India.

📋 Description

• Create, develop, tailor, and manage reports and dashboards for Oracle Argus Safety case management, expedited reporting, case processing, and regulatory submissions.

• Compose and optimize intricate SQL and PL/SQL queries, procedures, and views to extract, transform, and reconcile data from Oracle Argus Safety databases.

• Conduct unit, functional, and data validation testing to ensure that report outputs, calculations, filters, and aggregations are precise and compliant.

• Build dashboards and visualizations that monitor Pharmacovigilance metrics, case volumes, processing timelines, and compliance indicators.

• Convert business and Pharmacovigilance requirements into technical specifications, design documents, test scripts, and validation documentation.

• Assist with User Acceptance Testing, report deployment, post-deployment verification, and resolution of production issues.

• Diagnose data discrepancies, report execution failures, and performance challenges; optimize queries to enhance execution speed.

• Upgrade reporting solutions and set up report scheduling and automated distribution.

• Aid reporting activities during Argus upgrades, application enhancements, and database migrations.

• Discover opportunities to automate manual reporting and collaborate with cross-functional teams to address Argus Safety data and reporting challenges.

• Work closely with business analysts, Pharmacovigilance stakeholders, technical teams, and global client teams.

• Adhere to 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 field.

• 4-6 years of experience in IT application development, reporting, BI development, or technical consulting.

• Practical experience in 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.

• Proficient in SQL and PL/SQL, including complex queries, joins, subqueries, functions, and stored procedures.

• Familiarity with Oracle databases and the report development lifecycle, encompassing requirements analysis, design, development, testing, validation, and deployment.

• Solid understanding of Pharmacovigilance business processes and the architecture of the Oracle Argus Safety database, especially Individual Case Safety Reports (ICSR).

• Experience in drug safety, Pharmacovigilance, clinical research, or a similar regulated environment.

• Comfortable working with Oracle databases, Oracle Argus Safety data, and structured report validation processes.

• Excellent communication, organization, and problem-solving abilities.

• Experience with aggregate and periodic safety reporting, such as PSUR, PBRER, and DSUR.

• Background in 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.

• Familiarity with 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 broaden skills in Pharmacovigilance and clinical research.