Safety Specialist/Safety Lead
Core
Manage clinical trial safety data, process serious adverse events (SAEs), and generate safety reports for sponsors and clients.
Role type
Senior individual contributor clinical safety specialist
Builds
Individual Case Safety Reports (ICSRs), safety narratives, and regulatory submissions
Domain
Clinical research / Pharmacovigilance
Required skills
SAE case processing, ICSR composition, medical coding, MedDRA, WHODrug, FDA safety regulations, ICH guidelines, global safety regulations, safety database management, narrative writing
Preferred skills
Nursing or pharmacy degree, clinical trial safety experience, Argus experience, CRO or pharmaceutical industry experience
Responsibilities
Develop safety management plans, manage SAE intake to regulatory reporting, perform data entry and medical coding, QC safety documents and reports, prepare safety reporting and coding plans, provide safety training, draft standard operating procedures
Seniority
Mid-to-Senior, hands-on IC