患者安全ソリューションスペシャリスト/ Patient Safety Solution Specialist

A global biotechnology research company is looking for a Patient Safety Solution Specialist. The selected applicant will support Clinical Safety operations, including processing and reporting adverse events from clinical trials and post-marketing sources.

Responsibilities:

• Manage the receipt, processing, and review of all adverse event reports from clinical trials or spontaneous sources
• Enter safety data into databases and tracking systems, and maintain adverse event tracking systems
• Write patient narratives and code adverse events accurately using MedDRA
• Determine listedness against the appropriate label for marketed products, if applicable
• Identify missing clinically significant information and ensure collection and follow-up
• Ensure expedited cases are processed and submitted to regulatory authorities, clients, and other relevant parties within required timelines
• Process, review, and report Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) to clients, Regulatory Authorities, Ethics Committees, and project personnel
• Perform database reconciliation with the Data Management team or sponsor/client as needed
• Participate in signal detection, trend analysis, and pattern recognition activities
• Assist in preparation of listings for IND reports, PSURs, DSURs, and other periodic reports
• Support, train, and mentor less experienced safety staff in case-handling and adverse event reporting
• Maintain a comprehensive understanding of SOPs, Work Instructions, and guidance documents related to safety management and pharmacovigilance
• Assist with review and update of Safety Management Plans, Reconciliation Plans, and other safety-specific plans
• Participate in project team and client meetings and coordinate safety study files for archiving at project completion
• Support audits, inspections, and root cause analysis, including CAPA plan development and implementation

Requirements:

• Non-degree: More than 2 years of Safety experience or 4-5 years of relevant experience
• Associate degree: More than 2 years of Safety experience or 3-4 years of relevant experience
• Bachelor’s or above: More than 1 year of Safety experience or more than 2 years of relevant experience
• Preferred fields: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas
• Good communication and presentation skills
• Familiarity with Good Clinical Practice (GCP) related to clinical safety documentation
• Familiarity with ICH Guidelines
• Familiarity with worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products
  

Preferred Requirements:

• Knowledge of medical and drug terminology
• Proficient in MS Office

About the Company:

A company specialising in a wide range of services and solutions in the healthcare and diagnostics industry. They provide innovative technologies, diagnostic testing, and data-driven insights to support medical professionals and improve patient outcomes.

Keywords:

医療, バイオテクノロジー, 製薬, 臨床安全性, 外資系

Job Ref: P4M06J