Pharmacovigilance Coordinator (Japanese Skills Required)
Core
Provide day-to-day support to the global Pharmacovigilance Department and In-country Clinical Caretaker by processing and reporting safety information throughout clinical trials.
Role type
Pharmacovigilance Coordinator
Builds
Safety reports (SAEs, RAEs) and pharmacovigilance documentation for clinical trials
Domain
Clinical research / Pharmacovigilance
Deliverable
client delivery
Required skills
Data entry, non-medical review/triage, quality control, literature search, database maintenance, safety query distribution
Preferred skills
Experience with safety databases, E2B reporting to PMDA, Japanese scientific database search
Technologies
Safety databases, E2B reporting systems, Japanese scientific databases, MS Office
Responsibilities
Serve as contact point for Safety Desk and clinical project teams; Data entry of safety reports into the safety database; Non-medical review/triage of incoming safety reports; Quality control of data entered in the safety database; Safety queries distribution to sites/investigators; Maintenance and timely update of project-specific SAEs distribution lists; Review and timely update of project-specific SAEs trackers; Conduct literature search in a dedicated Japanese scientific database and article triage; Maintain pharmacovigilance documentation and associated records.
Seniority
Entry-level to Junior, operational support
