Director Global Patient Safety Sciences
Core
Lead global patient safety strategy, surveillance, and benefit-risk assessment for assigned compounds in drug development.
Role type
Director, Global Patient Safety Lead
Builds
Safety strategies, regulatory documents (DSURs, PSURs, risk management plans), and safety profiles for new medicines.
Domain
Pharmaceutical / Clinical Safety
Required skills
Safety strategy leadership, drug development lifecycle expertise, signal management, benefit-risk assessment, regulatory document preparation, cross-functional influence, mentorship
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead safety strategy and Global Patient Safety support for assigned compounds; Direct safety surveillance, signal management, benefit-risk assessment, and safety profile communications; Prepare regulatory query responses and safety documents; Review Investigator Brochures, protocols, clinical study reports, complex ICSRs, and other safety data; Lead Safety Monitoring Teams and represent safety across strategic and oversight committees; Develop safety strategies for non-compound activities; Maintain safety procedures and drive continuous improvement; Cultivate cross-functional relationships and mentor junior safety scientists.
Seniority
Director, strategic leadership & mentorship