添文安全情報薬務担当者/医薬開発本部レギュラトリーアフェアーズジャパン薬事薬務

職種

• その他医薬品薬事/法規対応

• 医薬品PV/安全性情報担当

• その他医薬品臨床開発

仕事内容

Basic purpose of the job The manager of Regional Regulatory Lead of Electronic Package Insert and Safety Related Information Operation Japan [RRL JP PSO] has responsibilities for labeling management of J-Package Insert, and management of the operations in submission of PI and Health Authority Interaction (HAI) as liaison of health authorities on safety related information (SRI), as follows. Provision of strong leadership as the leader of task team J-Package Insert and adhere e-PI implementation and labeling compliance. Adhere regulatory compliance with reporting requirements on safety obligation tasks, for examples HAI, record, and tracking (Quality and Compliance for Safety Related Information to Health Authorities or SRIQC). Provide PI and safety-related information to relevant Boehringer Ingelheim stakeholders where needed (Precautionary information, PV System Master File, Webpostings, etc.).

求める能力・経験

Bachelor or master’s degree in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Technology or Agriculture with significant practical experience related to respective TA. Further degrees, e.g. Specialized Pharmacist or Master of Drug Regulatory Affairs are appreciated.

雇用形態

給与

700万円〜1,200万円

勤務時間

休日・休暇

社会保険

備考

配属先

転勤

住所

東京都品川区

制度

その他

制度備考