1+ months

Japan Drug Safety Unit, Reporting Office/

**/ Description of Primary Role & Responsibility**

1. / 1. Receipt and Assess of Foreign case information, Literature information, Safety information originating from quality

2. / 2. Submission to PMDA of safety information (adverse event information, Research Report and Safety Measure Report) of marketed/investigation Pfizer products

3. / Data entry and management on Global Safety Database

4. / Compliance with laws and regulations of Japan, and maintenance of safety compliance

5. / Contribution to domestic and foreign internal audit/regulatory inspection

6. / Response to regulatory query regarding to Individual Case Safety Report

7. / Contribution to projects relating to development of process relating to global safety

** / Qualifications**

/ Skill requirements

/ Experience of Pharmacovigilance and/or Safety Data Management (preferred)

/ Medical writing experience/skill (preferred)

PC / PC skill

/ Experience relating to Safety Database (preferred)

/ Background requirement

/ Medical qualification (e.g. Registered Pharmacist) or Science background at colleage 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

TOEIC 600 730 / English verbal communication and writing skill (TOEIC score more than 600 (must), or more than 730 (preferred))

/ Localtion / Tokyo Headquarter

/ Number of recruitment / Some


/ Please submit application form in both Japanese and English

Reading Writing / English reading and writing examination will be conducted

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


Posted: 2019-09-16 Expires: 2020-02-19

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