Technical Consultant plays a crucial role in pharmacovigilance, particularly in the context of the Argus Safety System data migrations. The responsibilities of an data migration consultant, as outlined, involve various aspects of data migration, data management, automation, and collaboration with clients and source application data provider teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Configure, maintain, and optimize Oracle Argus Safety to support pharmacovigilance operations and regulatory reporting requirements.
- Lead end-to-end pharmacovigilance data migration projects involving migration of safety data from legacy safety systems databases into target safety systems.
- Perform source system assessment, data profiling, gap analysis, and migration impact assessments to define migration strategies and project deliverables.
- Analyze and convert PostgreSQL databases, schemas, tables, views, indexes, sequences, functions, triggers, and stored procedures into Oracle Database/Oracle Autonomous Database (ADB) while ensuring data integrity and optimal performance.
- Design and maintain source-to-target mapping documents, transformation rules, migration specifications, and data conversion documentation.
- Develop SQL and PL/SQL scripts to support data extraction, transformation, loading (ETL), reconciliation, validation, and migration reporting activities.
- Perform data extraction, cleansing, standardization, transformation, and loading activities while ensuring accuracy, completeness, and regulatory compliance.
- Execute database schema conversion and optimize migrated database objects for Oracle Database and Oracle Autonomous Database (ADB).
- Conduct comprehensive data validation and reconciliation between source and target systems to verify successful migration of all pharmacovigilance data.
- Support migration of safety entities including Cases, Products, Events, Licenses, Studies, Regulatory Reports, Literature, Users, Workflow Data, Attachments, and Configuration Data.
- Develop and execute migration validation plans, reconciliation reports, exception reports, and post-migration verification activities.
- Participate and support in migration testing activities including System Integration Testing (SIT), User Acceptance Testing (UAT), Performance Testing, and Production Validation.
- Identify, troubleshoot, and resolve migration issues related to data quality, database conversion, mapping discrepancies, application configurations, and system integrations.
- Develop and maintain Oracle BI Publisher (BIP) reports and validation reports to support migration verification and operational reporting.
- Collaborate with Pharmacovigilance, Regulatory Affairs, Business Analysts, Database Administrators, Validation Teams, and Oracle Support throughout migration projects.
- Support system integrations between Oracle Argus Safety and external applications using APIs, web services, and interface technologies.
- Ensure migrated data and system configurations comply with GxP, FDA 21 CFR Part 11, EMA, ICH E2B(R3), GAMP 5, and organizational validation standards.
- Prepare and maintain migration documentation including Migration Plans, Data Mapping Specifications, Validation Documents, Technical Design Documents, SOPs, and Migration Summary Reports.
- Support Oracle Argus upgrades, cloud migrations, and database modernization initiatives involving Oracle Cloud Infrastructure (OCI) and Oracle Autonomous Database (ADB).
- Mentor junior consultants and provide technical guidance on migration methodologies, database conversion techniques, and Oracle Argus best practices.
- Recommend automation opportunities and continuous improvements to enhance migration efficiency, quality, and compliance.
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES
- Participate in end-to-end pharmacovigilance data migration projects, including data assessment, profiling, mapping, transformation, validation, and reconciliation activities.
- Strong expertise in PostgreSQL database administration and development.
- Hands-on experience converting PostgreSQL databases to Oracle Database and Oracle Autonomous Database (ADB).
- Experience with PostgreSQL-to-Oracle schema conversion, including tables, indexes, constraints, sequences, views, triggers, stored procedures, and functions.
- Strong SQL and PL/SQL programming skills.
- Experience developing migration scripts, stored procedures, packages, and automation utilities.
- Experience using Oracle SQL Developer Migration Workbench or equivalent schema conversion tools.
- Strong understanding of Oracle Database architecture, Oracle Autonomous Database (ADB), and performance tuning.
- Experience with ETL processes, data transformation, and migration automation.
- Ability to optimize SQL queries and improve migration performance for high-volume datasets.
- Perform end-to-end data assessment, profiling, cleansing, transformation, validation, reconciliation, and migration activities.
- Develop and maintain source-to-target mapping documents and migration specifications.
- Execute complex SQL-based reconciliation and data validation activities.
- Identify and resolve migration defects, mapping inconsistencies, and data quality issues.
- Conduct pre-migration, mock migration, production migration, and post-migration verification.
- Support migration testing including SIT, UAT, Regression Testing, and Production Validation. Page 4 of 4 CONFIDENTIAL ERD-3-01b, Job Description Template, Rev. 13.0, Eff. 02/22/2023
- Perform record-level reconciliation to ensure completeness, consistency, and accuracy of migrated pharmacovigilance data.
PREFERRED QUALIFICATIONS
- Bachelor’s degree/Masters Degree in IT Stream
- 7+ years of relevant experience in safety IT Systems
OUR CULTURAL BELIEFS:
Patient Minded I act with the patient’s best interest in mind.
Client Delight I own every client experience and its impact on results.
Take Action I am empowered and empower others to act now.
Grow Talent I own my development and invest in the development of others.
Win Together I passionately connect with anyone, anywhere, anytime to achieve results.
Communication Matters I speak up to create transparent, thoughtful and timely dialogue.
Embrace Diversity I create an environment of awareness and respect.
Always Innovate I am bold and creative in everything I do.
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