This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Technical Consultant based in India.
This role supports critical pharmacovigilance operations through the configuration, optimization, and administration of Oracle Argus Safety.
You will work at the intersection of technology, data, and drug safety, helping ensure reliable systems and compliant regulatory processes.
The position combines system configuration, data migration, SQL analysis, reporting, integrations, and validation activities.
You will collaborate closely with business, pharmacovigilance, regulatory, and IT stakeholders to translate requirements into effective technical solutions.
Your work will contribute to the accuracy, integrity, and traceability of safety data throughout its lifecycle.
The role also offers opportunities to improve workflows, automate processes, strengthen reporting capabilities, and support continuous system enhancements.
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.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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