Posted to MedZilla on 9/23/2017

Takeda Pharmaceuticals

US-MA, Lead Reports Developer - Global Patient Safety Evaluation 1701537-MZ


Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Lead Reports Developer - Global Patient Safety Evaluationin ourCambridgeoffice.

  • Provide expertise within the Global Patient Safety Evaluation (GPSE) group for implementation / operation of all ISIS Global reporting solutions
  • Work collaboratively with GPSE functions, GPSE Database Reporting and Analytics Lead, support and validation roles, IT teams and Quality Assurance to ensure excellent and efficient Global reporting systems and end-user support
  • Provide strategic technical input into planning, roadmap, and execution of the GPSE Database reporting and analytics systems requirements, ensuring Global regulatory requirements are met
  • Contribute to oversight of any vendor outsourced GPSE reporting activities


  • Proactively identify / document GPSE reporting end-user system needs and requirements
  • Provide strategic technical input into development of roadmaps / plans for implementing complete range of Business Intelligence (BI) capabilities (reporting, analysis, dashboards, etc) in response to GPSE requirements and related driving Regulatory guidance
  • Lead / perform user needs / requirements analysis, supporting build / maintenance of BI solutions, using Oracle, Cognos, and/or other applicable technologies, including definition of requirements, designs, source code development, unit testing, maintenance, and migration
  • Lead / execute tuning / optimization of Global reporting solutions, including identifying / mitigating risks in proposed solutions
  • Lead / execute Global custom report and/or 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/or GPSE requirements
  • Provide strategic technical input into the definition / documentation of Global reporting development and related process standards, procedures, best practices
  • Research and/or contribute to implementation of automated processes, driving improved overall efficiency in all areas of GPSE Reporting and Analytics service delivery
  • Perform audit / inspection support related to GPSE Reporting and Analytics
  • Development, tracking, and reporting of quality metrics for GPSE reports
  • Provide strategic technical input / support of GPSE DB Reporting and Analytics technology projects as required
  • Provide mentoring, training and best practices for ad-hoc query and other Global report developers


  • Bachelors degree required; Advanced degree preferred
  • Experience with Patient Safety/Drug Safety Systems, including underlying DB data models, and associated Business Intelligence Reporting Systems (Argus, Insight, Cognos, Spotfire, SSRS, etc preferred) business support and/or maintenance
  • Expert knowledge of database programming languages, concepts, and query tools, including Oracle SQL, PL/SQL, Windows and/or Unix Shell scripting, etc
  • Strong understanding of Software Development Life Cycle (SDLC), including requirements gathering, technical design, and unit to system and user acceptance testing
  • Experience with Computer Systems Validation, including understanding of 21 CFR Part 11, GxP compliance and validation in a regulated environment
  • Process oriented focus
  • General knowledge of drug development process, including excellent knowledge of Patient Safety regulations and guidance as applies to regulated Patient Safety computer systems
  • Excellent analytical skills
  • Excellent written and verbal communication skills
  • Excellent organizational and time management skills
  • Working knowledge of MedDRA
  • Ability to establish sound working relationships with people globally, in various functions with a wide variety of disciplines and backgrounds
  • Contribute to oversight of outsourced GPSE reporting activities


  • Some travel to global Takeda sites may be required.


  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit

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