This is a fully remote position, open to applicants in Japan.

📋 Description

• Create comprehensive safety management plans.

• Oversee serious adverse event (SAE, SUSARS) cases from initial intake to regulatory reporting.

• Offer safety expertise to team members, clients, and personnel at study sites.

• Collaborate with sponsors, vendors, and internal team members to develop and implement safety collection tools, processes, and reporting systems.

• Engage in the assessment and establishment of safety databases for SAE data.

• Conduct intake, triage, data entry, medical coding, expectedness assessment, narrative composition, and analyses of similar events for individual case safety reports (ICSRs).

• Execute quality control checks on documents and safety reports.

• Prepare and/or review project-specific safety reporting plans and medical coding strategies.

• Develop and/or evaluate safety training materials.

• Deliver safety training and supervision for consultants, contractors, and/or staff.

• Review and/or draft standard operating procedures and work instructions.

• Support clients and departmental staff with safety-related evaluations and additional services.

• Carry out other assigned duties.

⛳️ Requirements

• Bachelor’s degree (BA/BS).

• At least 5 years of experience in safety.

• Health care professional background.

• Practical experience with global safety databases, SAE case processing including narrative writing, and the generation of safety reports.

• Familiarity with MedDRA and WHODrug.

• Knowledge of FDA safety regulations, ICH guidelines, and international safety regulations.

• Nursing or pharmacy degree is preferred.

• Experience in clinical trial safety.

• Practical experience with Argus.

• Industry experience in a Contract Research Organization (CRO) or pharmaceutical company is preferred.

🏝️ Benefits

• Regular full-time employment.

• Option for remote work from Japan.