Job Description

1. Database Design and Development: Design, develop, and maintain Argus Safety / LSMV Database configurations, including case forms, workflows, and business rules, to meet regulatory requirements and business needs. Implement database schema changes, data migrations, and system upgrades in collaboration with stakeholders and IT teams. 2. Customization and Configuration: Customize Argus Safety / LSMV Database functionalities and user interfaces to enhance user experience, streamline workflows, and improve efficiency. Configure and maintain data entry screens, validation rules, and data outputs to ensure data integrity and compliance with regulatory standards. 3. Technical Support and Troubleshooting: Provide technical support and troubleshooting assistance to end-users for Argus Safety / LSMV Database-related issues, including system errors, data discrepancies, and user inquiries. Collaborate with IT support teams to resolve technical issues, perform root cause analysis, and implement corrective actions. 4. System Integration & Data Migration: Integrate Argus Safety / LSMV Database with other pharmacovigilance systems, external databases, and third-party applications to facilitate data exchange and reporting requirements. Migration of PV data from one PV Safety system to other. Develop and maintain interfaces, data mappings, and integration scripts to ensure seamless data flow and interoperability. 5. Documentation and Compliance: Maintain comprehensive documentation of Argus Safety / LSMV Database configurations, customizations, and system changes in accordance with regulatory guidelines and internal procedures. Ensure compliance with regulatory requirements, including FDA regulations, EudraVigilance guidelines, and ICH guidelines, related to pharmacovigilance data management and reporting. 6. Database maintenance Database installation, maintenance and upgrade of Argus and LSMV systems. Requirements: Bachelor's degree in Computer Science, Information Technology, Life Sciences, or related field. Minimum of 7 years of experience in database development, with specific expertise in Argus Safety Database configuration and customization. Proficiency in Oracle SQL, PL/SQL, and database management tools. Strong knowledge of PLSQL query blocks / functions / packages/ database jobs/ triggers/ indexes , pivot queries & aggregate functions. Proficiency in data definition language table, column, views etc. Experience in pharmacovigilance or drug safety operations within the pharmaceutical or biotechnology industry. Experience in overall database design and architecture for custom solutions. Performance tuning knowledge. Strong understanding of pharmacovigilance processes, regulatory requirements, and industry best practices. Excellent problem-solving skills, attention to detail, and ability to work effectively in a fast-paced environment. Effective communication skills and ability to collaborate with cross-functional teams and stakeholders.