Senior Pharmacovigilance Data Migration Consultant – Oracle Argus Safety

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

📋 Description

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

• Oversee comprehensive pharmacovigilance data migration initiatives from legacy safety systems to target safety systems.

• Conduct source assessments, data profiling, gap analyses, and migration impact evaluations.

• Transform PostgreSQL databases and schema objects into Oracle Database and Oracle Autonomous Database while ensuring data integrity and performance.

• Create and uphold source-to-target mappings, transformation rules, migration specifications, and conversion documentation.

• Develop SQL and PL/SQL scripts for extraction, transformation, loading, reconciliation, validation, and reporting purposes.

• Execute data extraction, cleansing, standardization, transformation, and loading processes.

• Perform data validation and reconciliation between source and target systems.

• Facilitate the migration of Cases, Products, Events, Licenses, Studies, Regulatory Reports, Literature, Users, Workflow Data, Attachments, and Configuration Data.

• Formulate migration validation plans, reconciliation reports, exception reports, and post-migration verification activities.

• Assist with SIT, UAT, Performance Testing, Regression Testing, and Production Validation.

• Diagnose migration issues related to data quality, database conversion, mappings, configurations, and integrations.

• Create and sustain Oracle BI Publisher reports and validation reports.

• Collaborate with teams in Pharmacovigilance, Regulatory Affairs, Business Analysis, Database Administration, Validation, and Oracle Support.

• Facilitate integrations between Oracle Argus Safety and external applications utilizing APIs, web services, and interface technologies.

• Ensure adherence to GxP, FDA 21 CFR Part 11, EMA, ICH E2B(R3), GAMP 5, and validation standards.

• Develop migration plans, data mapping specifications, validation documentation, technical design documents, SOPs, and migration summary reports.

• Assist with Oracle Argus upgrades, cloud migrations, OCI, and ADB modernization projects.

• Mentor junior consultants and advocate for automation and continuous improvements.

⛳️ Requirements

• Extensive knowledge in PostgreSQL database administration and development.

• Practical experience in converting PostgreSQL databases to Oracle Database and Oracle Autonomous Database (ADB).

• Proficiency in PostgreSQL-to-Oracle schema conversion, encompassing tables, indexes, constraints, sequences, views, triggers, stored procedures, and functions.

• Strong command of SQL and PL/SQL programming.

• Experience in developing migration scripts, stored procedures, packages, and automation tools.

• Familiarity with Oracle SQL Developer Migration Workbench or similar schema conversion tools.

• Robust understanding of Oracle Database architecture, Oracle Autonomous Database (ADB), and performance tuning.

• Experience with ETL processes, data transformation, and migration automation techniques.

• Capability to optimize SQL queries and enhance migration performance for large datasets.

• Competence in performing data assessments, profiling, cleansing, transformation, validation, reconciliation, and migration tasks.

• Ability to create and maintain source-to-target mapping documents and migration specifications.

• Proficiency in executing complex SQL-based reconciliation and data validation tasks.

• Skill in identifying and rectifying migration defects, mapping inconsistencies, and data quality challenges.

• Experience in conducting pre-migration, mock migration, production migration, and post-migration verification processes.

• Experience in supporting SIT, UAT, Regression Testing, and Production Validation.

• Bachelor’s or Master’s degree in IT Stream (preferred qualification).

• Over 7 years of relevant experience in safety IT Systems.

🏝️ Benefits

• Great Place to Work certification.

• Equal Opportunity Employer.

• Commitment to Diversity, Equity & Inclusion.

• Cultural values that emphasize patient-centered work, client satisfaction, professional growth, talent development, innovation, and collaborative inclusivity.