Senior Manager, Global Patient Safety - Hematology

Role Summary

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.

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

Qualifications

• Required: Minimum a Master's, PhD, or PharmD
• Required: Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
• Preferred: Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
• Preferred: Ability to work with a safety system database for purposes of medical case review and simple queries
• Preferred: Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize
• Preferred: Ability to effectively communicate (verbal and written) safety findings