Clinical Safety Coordinator - Pharmacovigilance / Drug Safety
Core
Collect, process, and track serious adverse event (SAE) reports; generate safety narratives and queries; prepare clinical safety documents for global trials.
Role type
Clinical Safety Coordinator (Pharmacovigilance)
Builds
Safety cases, periodic safety reports, Investigator Safety Letters, and aggregate safety summaries for biopharma clients.
Domain
Clinical Research / Pharmacovigilance / Drug Safety
Deliverable
client delivery
Required skills
SAE reporting, safety database management, safety narrative generation, quality control of safety cases, GCP compliance, medical terminology knowledge, aggregate reporting coordination
Preferred skills
Argus safety database proficiency, experience with global trials, training new coordinators
Technologies
Argus
Responsibilities
Collect, process, and track serious adverse event (SAE) reports; Generate safety narratives and queries; Perform quality control of safety cases; Generate Investigator Safety Letters; Prepare clinical safety documents (safety management plan, periodic safety reports); Lead clinical trial projects to ensure client deliverables; Train new Clinical Safety Coordinators
Seniority
Mid-level, hands-on IC
