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 includes 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

Requirements

• Minimum a Master's, PhD, or PharmD
• Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
• Able 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
• Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize
• Able to effectively communicate (verbal and written) safety findings

Qualifications

• PhD in a relevant field
• Experience in pharmacovigilance, risk management, and/or regulatory affairs
• Strong analytical and problem-solving skills
• Excellent communication and presentation skills

Skills

• Expertise in pharmacovigilance and risk management
• Knowledge of FDA, EU, and ICH guidelines and regulations
• Ability to manage and analyze large datasets
• Strong verbal and written communication skills

Benefits

• 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
• Family support benefits

Pay

$150,500.00 - $245,500.00 annually

Schedule

Hybrid; 4 days per week on site