Experienced Clinical Safety Coordinator (Drug Safety)
Medpace · Région métropolitaine de Buenos Aires
Descripcion del puesto
About the role
Medpace is seeking a full‑time, office‑based Clinical Safety Coordinator to support its rapidly growing Latin American activities. The role is central to the pharmacovigilance process, working with global and local teams to ensure safety reporting compliance.
Key responsibilities
- Oversee submission of safety reports to Competent Authorities and Ethics Committees in accordance with regulatory timelines.
- Interact regularly with Clinical Operations, Data Management, and Regulatory Submissions teams worldwide.
- Draft study‑specific safety documents as required.
- Collaborate with a global team to distribute safety reports across regions.
Required profile
- Bachelor’s degree in a life‑science discipline.
- Minimum three years of experience in drug safety and safety reporting to regulatory authorities in Spanish‑speaking LATAM countries.
- Demonstrated knowledge of Good Clinical Practice (GCP) guidelines and medical terminology.
- Fluency in both Spanish and English.
Required skills
- Proficiency with Electronic Data Capture (EDC) systems and other clinical databases.
- Knowledge of applicable safety reporting guidelines.
- Strong attention to detail.
What we offer
- Competitive compensation and performance‑based rewards.
- Comprehensive health, wellness, retirement, and PTO benefits.
- Office‑based environment with occasional remote work flexibility after training.
- Mentorship, defined career paths, and continuous learning opportunities.
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Publicado hace 23 horas
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Medpace
Région métropolitaine de Buenos Aires
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