Clinical Safety Coordinator - Pharmacovigilance (Nursing Professionals Encouraged to Apply)
Core
Full-time Clinical Safety Coordinator supporting pharmacovigilance operations and regulatory reporting in South Korea.
Role type
Clinical Safety Coordinator (Pharmacovigilance)
Builds
Safety reports and regulatory submissions for clinical trials and post-marketing studies
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Pharmacovigilance experience, regulatory reporting, document translation (Korean/English), quality control review, adverse event processing
Preferred skills
Life Science degree
Technologies
SUSAR reporting systems, regulatory authority portals
Responsibilities
Generate safety letters and submit SUSAR/aggregate reports to South Korean regulatory authorities; Conduct quality control reviews of safety reports and department documents; Process clinical trial and post-marketing serious adverse events; Translate safety documents between Korean and English; Track and organize safety-related documents
Seniority
Mid-level, hands-on IC