Lead Report Developer

Role Summary

Lead Report Developer responsible for delivering PV reporting and analytics solutions, building BI capabilities, and leading global reporting initiatives within Takeda’s Pharmacovigilance function. Remote work allowed up to 100%.

Responsibilities

• Deliver pharmacovigilance reporting and 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 to enhance understanding of tools and techniques.
• Identify and document Global Pharmacovigilance reporting end-user system needs and requirements.
• Provide strategic technical input into roadmaps and plans for implementing BI capabilities (reporting, interactive analysis views, dashboards) in response to user requirements and regulatory guidance.
• Lead and perform user needs and requirements analysis; support construction and maintenance of BI solutions using Oracle, Cognos, and other applicable technologies, including requirements definition, designs, source code development, unit testing, maintenance, and migration.
• Lead tuning and optimization of global reporting solutions and mitigate risks in proposed solutions.
• Lead and execute global custom report and ad hoc query development; contribute to prioritization, planning, and execution of global reports.
• Lead complex global system and data investigations supporting end-user inquiries and Global Pharmacovigilance requirements.
• Provide strategic technical input into the definition and documentation of global reporting development standards, procedures, and best practices.
• Research and implement automated processes to improve efficiency in Global PV Reporting and Analytics service delivery.
• Perform audit and inspection support related to Global PV Reporting and Analytics.
• Develop, track, and report quality metrics for Global PV reports.
• Provide strategic technical input and support for 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.

Qualifications

• Required: Bachelor’s degree in Computer Science, Data Science, Pharmaceutical or Life Science or related field plus 5 years of related experience.
• Required: Experience with drug safety systems and underlying data models; ability to design, develop, document, test, and deploy custom reports, dashboards, and database views that meet user or regulatory requirements.
• Required: Ability to plan, manage, and implement small projects following SDLC principles.
• Required: Experience with computer systems validation activities related to 21 CFR Part 11 and GxP compliance; including requirements gathering, technical specifications, and user acceptance testing.
• Required: Analyze user feedback to identify and remediate issues with the global safety database and its data.

Skills

• Strong BI and reporting tools experience (Oracle, Cognos, etc.).
• Data analysis, statistics, and exposure to AI/ML techniques for data support.
• Requirements gathering, documentation, and stakeholder collaboration.
• End-to-end development of reports, dashboards, and data views.
• Project management and prioritization skills.

Education

• Bachelor’s degree in Computer Science, Data Science, Pharmaceutical or Life Science or related field

Additional Requirements

• Location: Cambridge, MA (Boston area); remote work up to 100% allowed.
• Employment type: Full-time.