[JDSU] 医薬品安全性統括部 ケースマネジメントチーム（一般社員） （Staff, Case Management, Japan Drug Safety Unit）

Responsibilities

Collection and Assessment of safety information (adverse event information) of marketed/investigation Pfizer products; Data entry and management on Global Safety Database; Compliance with laws and regulations of Japan, the United States and Europe, and maintenance of safety compliance; Contribution to domestic and foreign internal audit/regulatory inspection; Response to regulatory query regarding to Individual Case Safety Report; Contribution to projects relating to development of process relating to global safety

Requirements

PC skill; Fluent Japanese language capability (able to understand and explain Japanese regulation in Japanese, able to develop regulatory documents to be submitted in Japanese.); Medical qualification (e.g. Registered Pharmacist) or Science background at colleague or above; To be able to find and solve challenges points in daily work practically and constructively; To make a decision with good expectation of outcome of the decision; To achieve personal goals in addition to fulfilling quality level of work required in the department; To be able to work as a team; English verbal communication and writing skill (TOEIC score more than 600)

Nice to have

Experience of Pharmacovigilance and/or Safety Data Management (preferred); Medical writing experience/skill (preferred); Experience relating to Safety Database; TOEIC score more than 730 (preferred)