Safety Specialist/Safety Lead (Clinical Research)

Location: Remote, Japan

Company

hirify.global is a clinical research organization supporting precision medicine through clinical trial operations, medical expertise, biomarker solutions, and data analytics.

What you will do

• Develop safety management plans and manage serious adverse event (SAE) and SUSAR cases from intake through regulatory reporting.
• Support the design and implementation of safety collection tools, processes, reporting systems, and safety databases.
• Perform case intake, triage, data entry, medical coding, expectedness assessment, narrative writing, and similar-event analyses for individual case safety reports.
• Conduct quality control of safety documents and reports.
• Prepare or review project-specific safety reporting plans, medical coding plans, training materials, standard operating procedures, and work instructions.
• Provide safety expertise, training, and oversight to clients, consultants, contractors, staff, vendors, and study site personnel.

Requirements

• BA or BS degree.
• At least 5 years of safety experience.
• Healthcare professional qualification.
• Hands-on experience with global safety databases, SAE case processing, narrative writing, and safety report generation.
• Working knowledge of MedDRA, WHODrug, FDA safety regulations, ICH guidelines, and global safety regulations.

Nice to have

• Nursing or pharmacy degree.
• Clinical trial safety experience.
• Hands-on experience with Argus.
• Experience in a CRO or pharmaceutical company.

Culture & Benefits

• Remote work from Japan.
• Collaboration with sponsors, vendors, clients, internal teams, and study site personnel.
• Work across precision medicine, rare diseases, oncology, and other therapeutic areas.