Manager, Pharmacovigilance Systems

This position is responsible for Global Patient Safety (GPS) business support and strategy of the safety systems applied 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 chipping in to and reviewing user requirements for new PV systems, supplying 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.

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

• Collaborate with GPS end users and Global Development Solutions 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 alliance partners
• Fix user-reported issues of diverse scope
• Liaise closely with the Global Development Solutions safety systems team and led service team, in the support and maintenance of GPS systems
• Contribute to and review user requirements for new GPS systems projects; supply and review project-related validation documentation
• Implement 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 GDS on continuous improvement opportunities for systems, reports and end user

This role might be for you if...

• Minimum 5 years’ PV experience, with a minimum of 3 years’ safety database-specific experience

• A minimum of a Bachelors degree or equivalent work experience

#GDPSJobs

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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$102,600.00 - $167,400.00