Pharmacovigilance Reporting Associate

【求人No NJB2204577】
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.

・ 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