Japan Local Case Advisor

• Case Intake（Submission） • Accept, validate, and perform preliminary assessment of local safety cases, including phone calls with reporters • Handle personal information and confidential data per regulatory guidelines • Implement routine quality checks and undertake manual follow-up if required • Collaborate with internal partners to clarify or triage case information • Flag urgent or reportable cases for blocking issue resolution • Local Data Entry (applicable for both Japan domestic cases and Foreign cases) • Perform data entry into relevant safety database systems with high accuracy • Connect with internal collaborators to resolve data entry issues • Request follow-up information using specific product/event-related questionnaires • Audit / Inspection Readiness • Implement Corrective and Preventative Actions for local non-compliance • Follow SOPs for filing and archiving safety documentation • Support team in audits and regulatory authority inspections • Regulatory Compliance • Ensure adherence to Japanese regulatory standards for ICSRs and AE reporting • Call out urgent or high-risk cases following established procedures • Quality Management System (QMS) • Contribute to effective operational implementation of the QMS • Maintain knowledge of Japanese product portfolio and regulation changes • General / Others • Perform Peer review and ad-hoc project specific tasks as assigned • Collaborate on PV aspects related to Organised Data Collection Programmes

职位描述

职位要求