Technical Consultant

Accountabilities: • Configure, maintain, and optimize Oracle Argus Safety to support pharmacovigilance operations and regulatory reporting requirements.

• Analyze business requirements and implement system configurations, workflows, business rules, and automation aligned with regulatory standards and industry practices.

• Participate in end-to-end pharmacovigilance data migration projects, including data assessment, profiling, mapping, transformation, validation, and reconciliation.

• Collaborate with business, pharmacovigilance, regulatory, and technical stakeholders to define migration requirements and source-to-target mapping specifications.

• Perform data extraction, transformation, cleansing, validation, and reconciliation to ensure the accuracy, completeness, and integrity of migrated safety data.

• Develop and optimize SQL queries, stored procedures, and scripts for data analysis, reporting, migration validation, and issue investigation.

• Identify and resolve application, configuration, integration, data, mapping, and migration-related issues within the Argus Safety environment.

• Support integrations between Argus Safety and external applications using web services and related technologies.

• Design, develop, customize, and maintain Oracle BI Publisher reports, line listings, dashboards, and regulatory outputs.

• Create and optimize data models, report templates, and layouts to support operational, regulatory, and management reporting requirements.

• Participate in system integration testing, user acceptance testing, migration validation, and post-migration verification activities.

• Support system upgrades, enhancements, incident management, patch deployments, and related technical initiatives.

• Maintain migration documentation, validation evidence, test scripts, standard operating procedures, technical specifications, and reconciliation reports.

• Ensure system configurations, migrated data, reporting processes, and business workflows comply with applicable pharmacovigilance regulations and data governance standards.

• Provide end-user support, training, and documentation to promote effective system utilization and knowledge sharing.

• Monitor regulatory developments, product enhancements, reporting performance, and industry trends to identify opportunities for continuous improvement.

Requirements:

• Bachelor’s or Master’s degree in Information Technology or a related technical field.

• 3+ years of relevant experience working with drug safety or pharmacovigilance IT systems.

• Hands-on experience with Oracle Argus Safety configuration, administration, workflows, business rules, or related system capabilities.

• Experience supporting pharmacovigilance data migration projects, including source-to-target mapping, transformation, validation, reconciliation, and defect resolution.

• Strong SQL skills, with experience developing queries and scripts for data analysis, reporting, migration validation, and issue investigation.

• Experience with Oracle BI Publisher, including reports, line listings, templates, data models, and regulatory outputs.

• Knowledge of data extraction, transformation, cleansing, validation, reconciliation, and data quality practices.

• Experience participating in SIT, UAT, migration testing, and post-migration validation.

• Understanding of pharmacovigilance processes and global regulatory requirements, including applicable FDA and EMA standards.

• Ability to collaborate effectively with business stakeholders, Pharmacovigilance, Regulatory Affairs, IT, and technical teams.

• Strong analytical and problem-solving skills, with the ability to investigate complex data and application issues.

• Strong documentation and communication skills, with the ability to translate technical requirements into practical solutions.

• Experience supporting system integrations, web services, system upgrades, or technical enhancements is beneficial.

• Experience providing end-user support and training is preferred.

• Ability to work independently, manage priorities, and contribute effectively to projects involving multiple stakeholders.

• Familiarity with emerging pharmacovigilance technologies, Oracle BI Publisher enhancements, and data migration best practices is an advantage.

Benefits:

• Opportunity to work on critical pharmacovigilance and drug safety technology initiatives.

• Exposure to Oracle Argus Safety, data migration, SQL, Oracle BI Publisher, reporting, integrations, and validation activities.

• Collaboration with multidisciplinary teams spanning technology, pharmacovigilance, regulatory affairs, and business functions.

• Opportunity to contribute to system optimization, automation, data quality, and regulatory compliance.

• Experience working with global pharmacovigilance processes and regulatory requirements.

• Opportunities to develop expertise in healthcare technology, safety data, reporting, and data management.

• Remote work opportunity in India.

• Inclusive and collaborative working environment focused on healthcare and improving patient outcomes.

• Reasonable accommodations available to support individuals with disabilities in performing the essential functions of the role.

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