Experienced Clinical Safety Coordinator
Core
Full-time Clinical Safety Coordinator supporting pharmacovigilance processes for Medpace's Latin American activities.
Role type
Clinical Safety Coordinator (Pharmacovigilance)
Builds
Safety reports and study-specific safety documents for regulatory authorities in Spanish-speaking LATAM countries
Domain
Clinical Research / Pharmacovigilance / Drug Safety
Required skills
Safety reporting to regulatory authorities, Good Clinical Practice (GCP) guidelines, Electronic Data Capture (EDC) systems, Drug safety experience, Regulatory safety reporting guidelines
Preferred skills
None stated
Technologies
EDC systems, Clinical databases
Responsibilities
Oversight of submission of safety reports in the appropriate format to Competent Authorities/Ethics Committees in compliance with regulatory timelines; Regular interaction with other internal departments globally and locally; Draft study specific safety documents as required; Work in a global team to distribute safety reports globally
Seniority
Mid-level, 3+ years experience