Manager, Global Patient Safety

Tarrytown, NY, United States
Feb 08, 2021
Required Education
Bachelors Degree
Position Type
Full time
This position is to support the Global Patient Safety department in business support of safety systems utilized for pharmacovigilance. This includes daily activities such as reviewing user requirements for database configuration requests, and assessing and testing configuration updates before releasing to a Production state. It also includes project-specific responsibilities, such as contributing to and reviewing user requirements for new GPS 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 the Senior Manager, GPS Systems, for general supervision.

In this role, a typical day might include the following:
  • Collaborate with GPS end users and GDS to develop configuration requirements; document, perform and test configuration updates in the safety systems testing environments
  • Provide support for configuration and ongoing support of electronic reporting for health authorities and license partners
  • Troubleshoot user-reported issues of diverse scope
  • Liaise closely with the Global Development Systems safety systems team and managed service team, in the support and maintenance of GPS 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 systems change controls, and in accordance with Good Documentation Practices
  • Generate database searches and output in support of ad-hoc requests for safety data
  • As needed, assist in providing end user training on safety system related updates to internal GPS staff and external vendors responsible for case processing
  • Contribute to the production of system specific metrics and monitoring
  • Collaborate with the GDS on continuous improvement opportunities for systems, reports and end users
This role might be for you if:
  • Strong knowledge of safety database (Argus preferred)
  • Strong knowledge for Reporting Tools eg. OBIEE, Tableau etc. (please add others as examples)
  • Strong knowledge of front-end database configuration (Argus Console preferred)
  • Knowledge of generating advanced searches and developing reporting output
  • Experience in working with case intake systems preferred
  • Experience with configuration and testing of validated systems
  • Knowledge of relevant FDA, EU and ICH (International Conference on Harmonization) regulations governing clinical and post-marketing pharmacovigilance activities
  • Strong written and verbal communication skills, required for frequent communication with both internal and external contacts

We require a minimum 5 years' PV experience, with a minimum of 3 years' safety database-specific experience

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.