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

📋 Description

• Create safety management plans.

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

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

• Collaborate with sponsors, vendors, and internal teams to support safety collection tools, processes, and reporting systems.

• Contribute to the assessment and establishment of a safety database for capturing SAE data.

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

• Adhere to relevant regulations and company policies and procedures.

• Execute quality control for 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 oversight for consultants, contractors, and/or staff.

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

• Assist clients and departmental personnel with safety-related evaluations and additional services.

• Carry out other assigned duties.

⛳️ Requirements

• BA/BS degree required.

• At least 5 years of experience in safety.

• Background as a health care professional.

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

• Familiarity with MedDRA and WHODrug.

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

• Experience in clinical trial safety.

• Hands-on experience with Argus.

• Experience in the CRO or pharmaceutical industry.

🏝️ Benefits

• Regular full-time employment.

• Remote work arrangement in Japan.