Associate Director, Clinical Safety
Core
Oversee clinical safety case management, aggregate reporting, and safety review of clinical study documents for biotechnology and pharmaceutical clients.
Role type
Senior IC clinical safety manager (pharmacovigilance)
Builds
Safety plans, Standard Operating Procedures, guidelines, and narratives for clinical trials
Domain
Clinical research / Pharmacovigilance
Required skills
Clinical safety case management, aggregate reporting, safety review of protocols and study reports, SOP development, process improvement, team management, bilingual Japanese and English
Preferred skills
Leadership experience at a CRO, experience managing Clinical Safety Coordinators and Managers
Technologies
None stated
Responsibilities
Oversee clinical safety case management and aggregate reporting at a program level; Provide safety review of clinical study documents including protocols and study reports; Identify and manage process improvements and SOP updates; Act as an internal and external advisor on safety matters; Manage various levels of employees including Clinical Safety Coordinators and Managers
Seniority
Senior, hands-on IC with management responsibilities