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.


OBJECTIVES:
  • 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

ACCOUNTABILITIES:

  • 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

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • 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

TRAVEL REQUIREMENTS:

  • Some travel to global Takeda sites may be required.

WHAT TAKEDA CAN OFFER YOU:

  • 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

Learn more at takedajobs.com.

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 http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

#LI-KL1


Schedule
Full-time

Please visit our website at takedajobs.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.