[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.de
Tokyo, , Japan
Hybrid
Safety information collection and assessment
Global safety database management
Compliance with japan, us, eu regulations
This role involves collecting and assessing safety information for marketed and investigational Pfizer products while ensuring compliance with regulatory requirements in Japan, the US, and Europe
Job Summary
This role involves collecting and assessing safety information for marketed and investigational Pfizer products while ensuring compliance with regulatory requirements in Japan, the US, and Europe.
The position requires contribution to internal and regulatory audits, responding to individual case safety report queries, and participating in projects to develop global safety processes.
Applicants must submit application materials in both Japanese and English and will be based at Pfizer's Tokyo Headquarters with a hybrid work arrangement.
Matching Summary
This role involves collecting and assessing safety information for marketed and investigational Pfizer products while ensuring compliance with regulatory requirements in Japan, the US, and Europe.
Skills & Requirements
Must-have
Safety information collection and assessment
Global safety database management
Compliance with Japan, US, EU regulations
Regulatory inspection and audit response
English communication and writing skills
Nice-to-have
Pharmacovigilance experience
Medical writing skills
Safety database experience
Teamwork and problem solving
Project participation in global safety processes
Key Requirements
Fluent Japanese language capability
Medical qualification or science background
TOEIC score above 600
Ability to create regulatory documents in Japanese