[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）

Pfizer Pfizer · Pharma · Tokyo, Japan

This role involves collecting, assessing, and managing safety information for Pfizer's marketed and investigational products. Responsibilities include data entry into global safety databases, ensuring compliance with Japanese, US, and European regulations, supporting audits and inspections, responding to queries, and contributing to global safety process development projects. The role requires fluent Japanese, medical or science background, and English communication skills.

What you'd actually do

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

Skills

Required

  • PC skill
  • Fluent Japanese language capability
  • English verbal communication and writing skill (TOEIC score more than 600)
  • Medical qualification or Science background

Nice to have

  • Experience of Pharmacovigilance and/or Safety Data Management
  • Medical writing experience/skill
  • Experience relating to Safety Database
  • English verbal communication and writing skill (TOEIC score more than 730)

What the JD emphasized

  • Fluent Japanese language capability (able to understand and explain Japanese regulation in Japanese, able to develop regulatory documents to be submitted in Japanese.)
  • English verbal communication and writing skill (TOEIC score more than 600 (must), or more than 730 (preferred))