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Senior Manager, PV Systems

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Sep 24, 2022

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Job Details

This position is responsible for Global Patient Safety (GPS) business support and strategy of the safety systems utilized by the department. This includes daily activities such as reviewing user requirements for database configuration requests and assessing and testing configuration updates before releasing to Production. It also includes project-specific responsibilities, such as contributing to and reviewing user requirements for new PV systems, contributing to validation documentation, and performing support of database-related change controls. The position may be called upon to assist with training end users on database-specific updates and troubleshooting user-reported issues. This position reports to Associate Director, GPS Systems for general supervision but should have the ability to work independently.

In this role, a typical day might include the following:

  • Work with GPS end users to develop configuration requirements; document, perform and test configuration updates in the safety database testing environment
  • Provide support for configuration and ongoing support of electronic reporting for health authorities and partners
  • Troubleshoot user-reported issues of diverse scope
  • Liaise closely with the Global Development (GD) Systems team and managed service team, in the support and maintenance of GPS Safety Systems
  • Contribute to and review user requirements for new GPS systems projects, contribute and review project-related validation documentation
  • Execute Operational Qualification/Performance Qualification test scripts, in support of safety database change controls, and in accordance with Good Documentation Practices
  • Generate database searches and output in support of requests for safety data
  • Assist in providing end user training on safety system related updates for GPS organization and/or external vendors responsible for case processing, etc.
  • As needed, assist in the review of GPS Safety Systems and related SOPs, Work Instructions and other business practice tools (procedural documents)

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!


Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

    #GDPSJobs

    Company

    Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
     
    Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

    Stock Symbol: REGN

    Stock Exchange: NASDAQ

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    Company info
    Website
    Phone
    914-847-7000
    Location
    Corporate Headquarters
    777 Old Saw Mill River Road
    Tarrytown
    New York
    10591
    United States

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