Technical Consultant

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

📋 Description

• Configure, maintain, and enhance Oracle Argus Safety for pharmacovigilance operations and compliance reporting.

• Evaluate business needs and implement Argus configurations in accordance with regulatory requirements and industry best practices.

• Design, develop, and improve Argus workflows, business rules, and automation solutions.

• Engage in comprehensive pharmacovigilance data migration projects.

• Collaborate with business, safety, technical, Pharmacovigilance, Regulatory Affairs, and IT teams.

• Conduct data extraction, transformation, cleansing, validation, and reconciliation.

• Create SQL queries for data analysis, reporting, migration validation, and troubleshooting.

• Identify and address application, configuration, integration, data, mapping, and migration challenges.

• Facilitate integrations between Argus Safety and external applications.

• Develop, customize, and uphold Oracle BI Publisher reports and dashboards.

• Participate in SIT, UAT, system upgrades, enhancements, and migration validation activities.

• Ensure that configurations, migrated data, and reporting processes align with pharmacovigilance regulations and data governance standards.

• Assist with validation documentation, audits, inspections, upgrades, and regulatory reviews.

• Collaborate with Oracle Support and internal stakeholders regarding incidents, patches, and enhancements.

• Provide end-user support, training, documentation, and knowledge transfer.

• Stay updated on regulatory changes, Argus enhancements, BI Publisher advancements, and industry trends.

• Propose ongoing process and system improvements.

⛳️ Requirements

• Bachelor's degree/Master's degree in IT Stream (preferred).

• Over 3 years of relevant experience in drug safety IT systems.

• Proficient in Oracle Argus Safety configuration, maintenance, and optimization.

• Experience in pharmacovigilance data migration, including assessment, profiling, mapping, transformation, validation, and reconciliation.

• Experience in developing source-to-target mapping documents and data migration specifications.

• SQL-based data analysis, validation, reconciliation, and troubleshooting experience.

• Familiarity with Oracle BI Publisher reports, line listings, regulatory outputs, data models, templates, and report layouts.

• Proficient in SQL queries, stored procedures, and scripts.

• Understanding of system integrations, data interfaces, and web services.

• Experience with SIT, UAT, migration validation, and post-migration validation.

• Knowledge of global pharmacovigilance regulations, including FDA and EMA requirements.

• Experience in preparing migration documentation, validation evidence, test scripts, SOPs, and technical specifications.

🏝️ Benefits

• Great Place to Work certification.

• A culture focused on Diversity, Equity & Inclusion.

• Equal Opportunity Employer.

• Reasonable accommodations for individuals with disabilities.