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Lead Report Developer - Pharmacovigilance Group

Boston, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

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Lead Report Developer - Pharmacovigilance Group

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Job ID R0021757 Date posted 08/14/2020 Location Boston, Massachusetts

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Job Description

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 in our Cambridge, MA office.

OBJECTIVE: 

  • Provide expertise within the Global Pharmacovigilance group for implementation / operation of all ISIS Global reporting solutions
  • Work collaboratively with Global Pharmacovigilance functions, Global PV 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 Global PV Database reporting and analytics systems’ requirements, ensuring Global regulatory requirements are met
  • Contribute to oversight of any vendor outsourced Global PV reporting activities

ACCOUNTABILITIES: 

  • Proactively identify / document  Global Pharmacovigilance 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 Global Pharmacovigilance 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 Global Pharmacovigilance 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 Global PV Reporting and Analytics service delivery
  • Perform audit / inspection support related to Global PV Reporting and Analytics
  • Development, tracking, and reporting of quality metrics for Global PV reports
  • Provide strategic technical input / 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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelors degree required; Advanced degree preferred
  • Experience with Pharmacovigilance 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 Pharmacovigilance regulations and guidance as applies to regulated PV 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 Global PV reporting activities
  • Minimum of 8 years of technical systems experience required; preferably in Database Reporting, Development, Business Intelligence, or Data Warehousing

TRAVEL REQUIREMENTS:

  • As needed including possible international travel.

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

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0021757

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