Senior Manager, Global Patient Safety - General Medicine

Overview

The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post‑marketing phases in the assigned Therapeutic Area. The role includes safety data aggregation, review and analysis to support appropriate safety interpretation and benefit‑risk assessment.

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, and responses to health authority or other queries
• Prepare and deliver presentations at Signal Management Team (SMT) meetings and participate in clinical study team meetings for assigned compounds
• Participate in other risk management activities as appropriate for assigned compounds
• Represent GPS on cross‑functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), and other external teams
• Actively participate in process improvement initiatives such as development and maintenance of relevant SOPs, WIs, and supporting documents

• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post‑marketing environments
• Experience working with a safety system database for medical case review and simple queries
• Proactive, self‑disciplined, able to meet deliverables and effectively use time and prioritize
• Effective verbal and written communication of safety findings

• Minimum a Master’s, PhD, or PharmD
• Offers 7+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority

$ – $

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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Company’s business.