Company Overview
Contract Research Organization
Main Duties:
Safety Specialist
Pharmacovigilance operations for global clinical trials
Management of safety data for clinical trial and marketed drugs
Evaluation of safety information (global and domestic cases)
Data entry, drafting regulatory reports
Creation of PV-related documents
Client communication
Qualifications:
Required:
3 years pharmacovigilance experience
Strong understanding of PV processes (handling, triage, entry, QC, PMDA reporting, etc.), with ability to work independently
2 years of experience entering data into Argus, Aris, etc.
Preferred:
Background as a pharmacist, nurse, or other medical professional.
Experience in safety reporting and medical writing, including device malfunctions, labeling updates, regulatory documents, and reports in regenerative medicine and infectious diseases.