[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）
Core
Collecting, assessing, and managing safety information (adverse events) for marketed and investigational Pfizer products while ensuring compliance with Japan, US, and EU regulations.
Role type
Staff pharmacovigilance case management specialist
Builds
Global safety database entries and compliant individual case safety reports
Domain
Pharmaceutical industry + Pharmacovigilance
Required skills
Pharmacovigilance experience, Safety data management, Medical writing, Regulatory compliance knowledge, Japanese regulatory expertise, English communication, Data entry
Preferred skills
Safety database experience, High TOEIC score (730+), Science degree or medical qualification
Technologies
Global Safety Database, PC
Responsibilities
Collect and assess adverse event information for Pfizer products, Enter and manage data in the Global Safety Database, Ensure compliance with Japan, US, and EU safety regulations, Respond to regulatory queries regarding Individual Case Safety Reports, Participate in projects to develop global safety business processes
Seniority
Staff, hands-on IC
