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Experienced Clinical Safety Specialist
hace 2 meses
**Job Summary**
Medpace, Inc. is a leading contract research organization (CRO) providing clinical development services to the biotechnology, pharmaceutical, and medical device industries. We are seeking a highly skilled Clinical Safety Coordinator to join our team in a full-time, office-based position.
**Key Responsibilities:**
- Oversight of submission of safety reports in the appropriate format to regulatory authorities in compliance with regulatory timelines.
- Regular interaction with internal departments globally and locally, such as Clinical Operations, Data Management, and Regulatory Submissions.
- Drafting study-specific safety documents as required.
- Collaboration with a global team to distribute safety reports globally.
**Requirements:**
- Education to degree level, Bachelor of Science.
- Fundamental knowledge of Good Clinical Practice (GCP) guidelines and medical terminology.
- Knowledge of Electronic Data Capture (EDC) systems and other clinical databases.
- Experience in safety reporting to regulatory authorities in Spanish-speaking LATAM countries.
- Drug safety experience.
- Knowledge of applicable safety reporting guidelines.
- Strong attention to detail.
- 3 years of experience working within drug safety.
- Fluency in Spanish.
**About Medpace, Inc.**
Medpace is a full-service CRO providing Phase I-IV clinical development services. Our mission is to accelerate the global development of safe and effective medical therapeutics through our scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective.
