Senior Manager, Global Patient Safety - Immunology & Inflammation

Regeneron Pharmaceuticals•Armonk, NY

75d

About The Position

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. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. In this role, a typical day might include: 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 We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents This role might be for you if can/have the: 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 Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize Ability to effectively communicate (verbal and written) safety findings

Requirements

Minimum a Master's, PhD, or PharmD
Offers 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
Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize
Ability to effectively communicate (verbal and written) safety findings

Responsibilities

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
Represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents