The role serves as the principal owner for Safety Aggregate Report and Analytics Center deliverables including PBRERs, PSURs, and DSURs
Job Summary
The role serves as the principal owner for Safety Aggregate Report and Analytics Center deliverables including PBRERs, PSURs, and DSURs.
Candidates will lead signal detection activities, validate signals, and characterize risks for post-marketing and clinical trial projects.
The position requires interfacing with global project leads, regulatory agencies, and various functional groups such as Regulatory Affairs and Quality.
Matching Summary
The role serves as the principal owner for Safety Aggregate Report and Analytics Center deliverables including PBRERs, PSURs, and DSURs.
Skills & Requirements
Must-have
Safety aggregate reports and analytics
Signal management activities
Regulatory agency response authoring
Literature safety surveillance
Benefit risk management documents
Nice-to-have
Mentorship of less experienced resources
Technology innovation support
Cross-functional team leadership
Flexible to changing demands
Key Requirements
Bachelor's Degree in Scientific or Healthcare discipline