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Mgr Global Patient Safety

Job Description

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Responsible for proactively managing routine CERM deliverables and activities in accordance with applicable regulations and agreements.

Responsible for successful conduct of case processing activities for all investigational and marketed products to ensure timely processing of adverse events reports as described in the FDA Code of Federal Regulations, Regeneron Licensing Partners Safety Data Exchange Agreements and SOPs.

Supports new/ongoing phase IV/post-marketing studies.


  • Serves as a primary point of contact with vendor for managing routine activities and addressing related issues.
  • Serves as point of contact with PVRM senior management for updates and timely escalation of issues that require senior management attention.
  • Evaluates all adverse event reports received from the case processing vendor for accuracy and regulatory reporting. Monitors case finalization work stream and prepares reports for distribution.
  • Identifies and leads process improvement activities whether internal to group or PVRM; or involving groups external to PVRM or Regeneron, including vendors or License Partners.
  • Works effectively with external departments and License Partners on relevant PV deliverables (ex. works with Medical Affairs on post-marketing studies/programs).
  • Exercises independent judgment in managing case processing PV deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables.
  • Ensures development and maintenance of applicable SOPs and Working Instructions and training.
  • May be responsible for management of assigned personnel.
  • Works on problems of diverse scope which require analysis of situation or data.
  • Determines and pursue courses of action necessary to obtain desired results.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Frequently interacts with individuals at various management levels, including senior management, within and outside the organization to support vendor management and case processing deliverables. Interaction typically requires the ability to gain cooperation of others, conducting presentations of PV related information concerning specific projects or schedules.


  • Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
  • Act as subject matter expert in case processing and as a resource on relevant FDA, EU and ICH guidelines, initiatives and regulations.
  • Experience with and demonstrated success in working on cross-functional diverse teams required.
  • Demonstrated leadership of projects or teams.


  • Bachelor’s level degree in life sciences required. Pharmacy, nursing or equivalent required, advanced degree preferred.


  • Previous relevant experience in the pharmaceutical industry required; some degree requirements may be waived due to extensive experience
  • 10 plus years with Bachelor’s degree,
  • 7 plus years with Master’s degree, and
  • 5 plus years with advanced degree (ex. PharmD).

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)

$108,200.00 - $176,600.00