[한국화이자제약] Drug Safety Unit - Safety Data Management Specialist(1-year Contract)
한국화이자제약
Hybrid
Adverse drug experience reporting
Safety data collection and reconciliation
Pharmacovigilance regulations and guidelines
Review, preparation, and completion of reports of adverse drug experiences to determine the safety profile of Pfizer’s products and to meet regulatory requirements
Job Summary
Review, preparation, and completion of reports of adverse drug experiences to determine the safety profile of Pfizer’s products and to meet regulatory requirements.
Carry out case processing activities including reviewing, ranking, verifying, processing, and documenting case-related information.
Develop and maintain expertise and knowledge for applicable corporate and global regulations, guidelines, Standard Operating Procedures, data entry conventions, and search functions in the safety database.
Matching Summary
Review, preparation, and completion of reports of adverse drug experiences to determine the safety profile of Pfizer’s products and to meet regulatory requirements.
Skills & Requirements
Must-have
Adverse drug experience reporting
Safety data collection and reconciliation
Pharmacovigilance regulations and guidelines
Safety database search functions
Korean and English fluency
Nice-to-have
Problem-solving with supervision
Working in a matrix organization
Medical writing skills
Relational database management
Key Requirements
Bachelor's Degree
Fluency in Korean & English
Health Care Professional or equivalent experience preferred
Experience in pharmacovigilance and/or data management preferred
1-2 years of experience in pharmacovigilance or clinical research preferred