Senior Manager, Global Patient Safety - General Medicine

About the role

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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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

Requirements

• A minimum of a Master's, PhD, or PharmD degree
• 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
• Able to work with a safety system database for purposes of medical case review and simple queries
• Proactive and self-disciplined, able to meet deliverables and effectively use time and prioritize
• Able to effectively communicate (verbal and written) safety findings

Qualifications

• Ability to be proactive and self-disciplined
• Able to effectively communicate (verbal and written) safety findings

Skills

• Knowledge of 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 purposes of medical case review and simple queries
• Ability to complete signal detection activities in line with approved safety surveillance plan
• Ability to perform signal evaluation for any identified signals and author the safety evaluation reports
• Ability to manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
• Ability to prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
• Ability to participate in other risk management activities as appropriate for assigned compounds
• Ability 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
• Ability to actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

Benefits

• Competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits

Pay

$150,500.00 - $245,500.00 annually

Schedule

Hybrid; 4 days per week on site