Experienced Clinical Safety Coordinator (Drug Safety)
Core
Full-time Clinical Safety Coordinator supporting pharmacovigilance processes for Latin American activities by overseeing safety report submissions and drafting study-specific documents.
Role type
Clinical Safety Coordinator (Drug Safety)
Builds
Safety reports and regulatory submissions for Competent Authorities/Ethics Committees
Domain
Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Safety reporting to regulatory authorities, Drug safety experience, Knowledge of GCP guidelines, Knowledge of EDC systems, Spanish language proficiency, English language proficiency
Preferred skills
Experience in Spanish-speaking LATAM countries
Technologies
Electronic Data Capture (EDC) systems
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