Consultant

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

💼 Consultant

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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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