Lead Report Developer

Lead Report Developer

Requirements

• Bachelor’s degree in Computer Science, Data Science, Pharmaceutical or Life Science or related field plus 5 years of related experience
• Utilize knowledge of drug safety systems, including the underlying data model(s) to design, develop, document, test, and deploy custom reports, dashboards, and database views that meet user or regulatory requirements
• Plan, manage, and implement small projects in accordance with software/system development life cycle principles
• Contribute to computer systems validation activities as they relate to 21 CFR Part 11 & GxP compliance (e.g. user requirements gathering & definition, authoring of technical specification documents, authoring user acceptance tests)
• Analyze user feedback to identify and remediate issues with the configuration of the global safety database and its associated data.

Responsibilities

• Deliver pharmacovigilance (PV) reporting & analytic solutions for Takeda Patient Safety & Pharmacovigilance (PSPV)
• Identify and develop methods for statistics and AI/Machine Learning to support the department’s data needs
• Solve business problems in drug safety which provide an increased understanding of such tools and techniques
• Identify and document Global Pharmacovigilance reporting end-user system needs and requirements
• Provide strategic technical input into development of roadmaps and plans for implementing Business Intelligence (BI) capabilities (reporting, interactive analysis views, dashboards, etc.) in response to global pharmacovigilance user requirements and/or regulatory guidance
• Lead and perform user needs and requirements analysis, support construction and maintenance of BI solutions, using Oracle, Cognos, and other applicable technologies, which include definition of requirements, designs, source code development, unit testing, maintenance, and migration
• Lead and execute tuning and optimization of Global reporting solutions, including identification for mitigating risks in proposed solutions
• Lead and execute Global custom report and Global ad hoc query development; contribute to prioritization, planning, and execution of global reports
• Lead complex Global system and data investigations, supporting end-user inquiry and Global Pharmacovigilance requirements
• Provide strategic technical input into the definition and documentation of Global reporting development and related process standards, procedures, and best practices
• Research and contribute to implementation of automated processes, driving for improved overall efficiency in all areas of Global PV Reporting and Analytics service delivery
• Perform audit and inspection support related to Global PV Reporting and Analytics
• Development, tracking, and reporting of quality metrics for Global PV reports
• Provide strategic technical input and support of Global PV DB Reporting and Analytics technology projects as required
• Provide mentoring, training and best practices for ad-hoc query and other Global report developers.

Preferred Qualifications

No preferred qualifications provided.