Safety Systems Consultant – Oracle Argus
Location: Pune, India
Job Category: Clinical | Pharmacovigilance Systems
Employment Type: Full-Time
Experience Required: 3–5 Years
Job ID: 256243
Role Overview
We are seeking an experienced Safety Systems Consultant with strong expertise in Oracle Argus Safety Suite and PL/SQL development to support global pharmacovigilance and drug safety operations. This role plays a critical part in ensuring regulatory compliance, system integrity, and seamless safety data management across clinical and post-marketing environments.
The position is ideal for professionals with a blend of technical database skills and pharmacovigilance domain knowledge.
Key Responsibilities
Argus Safety & Database Development
Design, develop, and maintain PL/SQL procedures, functions, packages, and triggers supporting Argus Safety operations
Customize and configure Oracle Argus Safety Suite (v7.x / v8.x preferred) based on business and regulatory requirements
Perform ETL activities for safety data migration, reconciliation, and reporting
Systems Integration & Reporting
Support Argus Console configurations, E2B (R2/R3) transmissions, and third-party integrations
Integrate and manage MedDRA and WHO Drug dictionaries
Support safety system interfaces including Axway and other transmission tools
Collaboration & Validation
Partner with Pharmacovigilance operations, Business Analysts, QA, and IT teams
Participate in system validation activities, including IQ/OQ/PQ documentation
Troubleshoot and resolve Argus Safety, database, and performance-related issues
Data Quality & Compliance
Optimize database performance and ensure data accuracy, integrity, and audit readiness
Ensure compliance with ICH guidelines, global regulatory requirements, and GxP standards
Required Qualifications & Experience
Education
Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related discipline
Experience
3–5 years of hands-on experience in Oracle PL/SQL development
Practical experience working with Oracle Argus Safety Suite
Strong understanding of pharmacovigilance workflows and Argus data models
Technical & Domain Skills
Oracle PL/SQL performance tuning and query optimization
Experience with E2B reporting (R2/R3) and regulatory submissions
Familiarity with SDLC and System Validation Life Cycle (SVLC)
Knowledge of medical and drug terminology
Understanding of GCP, ICH guidelines, and global safety reporting requirements
Exposure to medical device reporting is an advantage
Tools: TOAD, SQL Developer, ERWIN, MS Office, Windows
Professional Competencies
Strong verbal, written, and presentation skills
High attention to detail and accuracy
Ability to work independently with minimal supervision
Proven team player with cross-functional collaboration skills
Ability to anticipate issues and implement corrective actions
Effective stakeholder communication at functional and tactical levels
Work Environment
Office-based or remote (role-dependent)
Collaborative, compliance-driven clinical and safety systems environment
Why Apply via ThePharmaDaily.com
Curated global opportunities in Pharmacovigilance, Drug Safety Systems, Clinical IT, and Regulatory Technology
Trusted platform for life sciences professionals and employers worldwide
Career growth with leading pharmaceutical and healthcare organizations
Apply now to advance your career in pharmacovigilance safety systems and Oracle Argus consulting.
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