Argus Safety Reporting Developer

Top Required Skills

• Argus Safety Database
• Oracle SQL / PL-SQL
• GxP / Computer System Validation

JD

We are seeking an experienced Lead Report Developer to develop, maintain, and optimize Global Pharmacovigilance (PV) reporting solutions.

The candidate will work on Argus Safety reporting, database queries, BI solutions, and system validation while ensuring GxP and regulatory compliance.

Key Responsibilities

• Develop and maintain custom reports, dashboards, and ad-hoc queries.
• Work with Argus Safety database and PV reporting systems.
• Develop complex queries using Oracle SQL and PL/SQL.
• Support BI reporting solutions using Cognos, Spotfire, SSRS, or similar tools.
• Perform system validation, testing, and reporting optimization.
• Ensure compliance with GxP, 21 CFR Part 11, and SDLC requirements.
• Support data investigations, audits, and regulatory inspections.

Required Qualifications

• Bachelor's degree required.
• 5+ years of experience in database reporting, development, BI, or data warehousing.
• Hands-on experience with Oracle Argus Safety and Pharmacovigilance reporting systems.
• Strong Oracle SQL and PL/SQL skills.
• Experience with GxP, Computer System Validation (CSV), and 21 CFR Part 11.
• Knowledge of Argus Insight, Cognos, Spotfire, or SSRS.
• Working knowledge of MedDRA and Pharmacovigilance regulations.
• Strong analytical, communication, and problem-solving skills.