[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 manager
Builds
Individual Case Safety Reports (ICSRs) and global safety database entries
Domain
Pharmaceutical industry, drug safety, regulatory compliance
Deliverable
client delivery
Required skills
Pharmacovigilance operations, safety data management, regulatory document creation, adverse event assessment, audit response, project participation
Preferred skills
Medical writing, safety database management
Technologies
Global Safety Database
Responsibilities
Collect and assess safety information for marketed/investigational products, enter and manage data in the Global Safety Database, ensure compliance with Japan/US/EU regulations, respond to regulatory queries on Individual Case Safety Reports, contribute to audit/inspection activities, participate in global safety process development projects
Seniority
Staff, individual contributor
