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Location Japan - Tokyo
Industry Life Sciences & Healthcare > Pharmaceuticals
Job functions Healthcare R & D > Drug Safety/PMS
Job number JO-170925-137033

Company overview


Job description

<製造販売後調査の実施管理者として、調査の計画/調査実施計画の立案、実施、 進捗管理および再審査対応関連業務をリード>
Take responsibility and lead for all activities and management of PMS such as survey planning/implementation, and re-examination process.

調査、試験実施の責任者として品質、タイムライン、費用、コミュニケー ション、リスク等の管理を行い、確実に調査を進める。
Responsible for PMS activities and implement these tasks with quality and within timeline and budget. Conduct risk analysis and ensure all tasks are compliant with related regulations and company procedures.

社内外のメンバー(CRO 及び共同販売提携先関係者を含む場合あり)から構 成されるクロスファンクショナルチームをリードし、調査実施計画に従って、調査を実施する。
Lead a cross-functional team composed of internal team members and external team members such as CROs and co-op promotion partners and conduct the surveillance studies.

Take responsibility to establish protocol, safety report, analysis plan, re-examination dossiers.

Holds regulatory correspondences with PMDA/MHLW timely and properly upon re-examination.

Trainings regarding PMS for related team members.

RMP および安全性定期報告の PMS 部分の作成等
Prepare PMS part of periodic safety reports and RMP

GPSP 手順書のメンテナンス
Update GPSP SOP.


BSc or above with natural science including medicine, Pharmacy. MSc or Ph.D. preferred

薬剤師 (尚可)
Licensed Pharmacist preferred

Business fluent in English in written and verbal

【求める経験・ス キル】
<必須 Requirements>
・製造販売後調査業務に精通(最低 5 年以上)
・GPSP、GVP、GCP、ICH 等関連法規・規制等の理解・習熟
・英語力(TOEIC700点程度目安:電話会議参加、Email コミュニュケーションなどが必要となるため)
・PC スキル(Excel、Word、PowerPoint、MS-Project)

・5 year + experience in PMS
・Good knowledge and skills regarding GPSP, GVP, GCP, ICH and related regulations.
・English skills (Meeting, email communications)
・Communication skills
・PC Skills: Excel、Word、PowerPoint、MS-Project

Additional information



3カ月 (試用期間中の勤務条件特になし)



09:00 ~ 17:30〔所定労働時間 7 時間 30 分 (休憩 60 分)〕