Experienced Clinical Safety Specialist
2 weeks ago
Medpace, Inc. is seeking a highly skilled Clinical Safety Coordinator to join our team in a full-time, office-based position. This role plays a critical part in the pharmacovigilance process, working closely with internal departments globally and locally to ensure compliance with regulatory timelines.
Key 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, 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.
- Bachelor's degree in a Life Science area required.
- Demonstrated 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.
- At least 3 years of experience working within drug safety.
- Fluency in Spanish.
Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through our scientific and disciplined approach.
Why Medpace, Inc.?We offer a dynamic work environment, competitive compensation and benefits package, and opportunities for professional growth and development. Our team is committed to making a positive impact on the lives of patients and families affected by disease.
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