Supervisor/Pharmacovigilance (Regulatory Operations)の求人情報なら転職エージェントJAC

求人情報

Supervisor/Pharmacovigilance (Regulatory Operations)

  • 週休二日制
  • 外資
求人番号

NJB1073226

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会社名 社名非公開 <業種:メディカル・バイオ - CRO>
職種

メディカル・バイオ-安全性情報(臨床開発/製販後GVP)

雇用形態 無期雇用
勤務地 東京都 大阪府
仕事内容

・Manage the flow of in-/out-bound safety reports based on case-trackers

・Review ICSR, DSUR and other necessary safety documents for safety assessment and regulatory/site submission and prepare a safety assessment sheet and approval form for each case

・Manage communication with vendors who are responsible for creating safety reports and make a submission plan for each case.

・Preparation and QC of Japanese ICSR and line-listing before regulatory/site submission

・Manage communication with Sponsor (in English and Japanese) for case handling and site safety reporting when necessary

・Submission of safety reports to regulatory authority and sites

・Ensure filing/digital storage of all the safety-related documents/forms in the processes aligned with the trackers

・Support the preparation and review of study Safety Management Plan

・Manage communication with Regulatory Authorities such as PMDA/MHLW, PFDA, etc. when requested and prepare necessary records/documentation

・When requested, support the preparation and review clinical trial documents (mainly translation) and coordinate with sponsor and Vendor for the translation schedule.

・Support tasks associated with Regulatory inspection

・Other administrative tasks such as invoice processing, affixing of company seal, and etc.

・Stay up to date with changes in regulatory legislation and guidelines and assess impact on product development

・Participate in internal and external meetings and trainings as necessary


■休日:完全週休二日制

求める経験、能力
年齢制限の理由

・Japanese: fluent/native

・English: business level or above

・Strong familiarity with J-GCP and Japanese regulations related to safety reporting for clinical trials

・Professional experience with responsibilities outlined above (preferably 5+ years)


■職種未経験者:不可

年収 550万円 - 850万円
語学力
英語力: 
上級

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