メディカル・バイオ - 安全性情報（臨床開発・製販後GVP）

<Overview>
• Serve as safety reporting processor or lead for multiple safety reporting, providing management support as designated.
• Recognize, exemplify, and adhere to ICON's values, which center around our commitment to People, Clients, and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our
processes adding value to our business and meeting client needs.
• Complete all departmental project activities accurately in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and client processes.
• Responsible for safety reporting or safety reporting intelligence activities on assigned projects, working in a customer focused approach and an audit and inspection ready mindset.
• Demonstrate skills pertaining to client management, safety reporting, project scope, submission compliance, quality, and budget.
<Detail>
• The following safety information case processing tasks related to clinical trials/post-marketing of pharmaceutical products
• Receipt of information on Adverse event, triage, numbering, confirmation of details, entry into database/QC
• Creation of explanatory text for case course (Japanese and English)/QC
• Primary evaluation of the necessity of reporting to the PMDA / QC of the evaluation details
• Preparation of reports to PMDA/QC
• Escalation, coordination, etc. to customers
• Operations incidental to the above
*Our Safety Reporting team will allow you to experience the ICCC study start-up, not just safety reporting. At first, senior members will support you. You could expand your experience.

■休日：完全週休二日制

• Experience required for any of the following
➢ PV experience, especially PMDA submission experience required.
Experience with ICCC is better.
➢ 2+ years of CRA experience
• Fluency in Japanese, business level English

■職種未経験者：不可