Sr Pharmacovigilance Data Migration Consultant

Job description

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. Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Follow us on LinkedIn | Twitter At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.