Senior Manager, Global Patient Safety – General Medicine

Regeneron

Senior Manager, Global Patient Safety managing safety strategies for clinical development and post-marketing phases at Regeneron. Involves signal detection, evaluation, and management of safety documentation.

Posted 5/20/2026full-timeWarren • Massachusetts • 🇺🇸 United StatesSenior💰 $150,500 - $245,500 per yearWebsite

About the role

Key responsibilities & impact

Complete signal detection activities in line with approved safety surveillance plan
Perform signal evaluation for any identified signals and author the safety evaluation reports
Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
Participate in other risk management activities as appropriate for assigned compounds
Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

Requirements

What you’ll need

Minimum a Master's, PhD, or PharmD
7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
Ability to work with a safety system database for purposes of medical case review and simple queries
Ability to effectively communicate (verbal and written) safety findings

Benefits

Comp & perks

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

signal detectionsignal evaluationsafety evaluation reportssafety documents preparationrisk managementprocess improvementSOPsWIs

Soft Skills

effective communicationpresentation skills

Certifications

Master's degreePhDPharmD