Pharmacovigilance Coordinator
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 regulatory submissions for novel pharmaceuticals and investigational devices
Domain
Clinical trials / Pharmacovigilance / Regulatory compliance
Deliverable
client delivery
Required skills
Safety report processing, data entry, quality control, literature search, database maintenance, safety query distribution, regulatory reporting
Preferred skills
Experience with safety databases, E2B reporting to PMDA, Japanese scientific database search
Technologies
Safety databases, E2B reporting systems, MS Office
Responsibilities
Serve as contact point for Safety Desk and clinical project teams, non-medical review/triage of incoming safety reports, data entry and quality control of safety reports, distribute safety queries to sites/investigators, maintain SAEs distribution lists and trackers, conduct literature searches and article triage, maintain pharmacovigilance documentation, communicate with investigators on safety reporting rules
Seniority
Mid-level, hands-on IC
