Clinical Safety Specialist
Há 5 dias
SAO Fortrea Brazil Limitada is seeking a highly motivated and detail-oriented Clinical Safety Specialist to join our team. As a Clinical Safety Specialist, you will play a critical role in ensuring the safety of our clients' products and adhering to regulatory requirements.
Key Responsibilities:- Perform case intake and triage of incoming safety information or reports from various sources.
- Assist with processing of adverse events, including data entry, writing patient narratives, and coding adverse events using MedDRA.
- Assist in the assessment of listedness against appropriate labels and generation of queries for missing or discrepant information.
- Submit expedited SAE reports to clients, regulatory authorities, and other stakeholders within agreed timelines.
- Assist with processing and submission of periodic reports to worldwide regulatory agencies.
- BA/BS Degree in healthcare courses.
- Fluency in English and Spanish.
- Basic MS Office knowledge.
Fortrea is committed to revolutionizing the development process and ensuring the swift delivery of life-changing ideas and therapies to patients in need. As a Clinical Safety Specialist, you will have the opportunity to make a meaningful global impact while working in a collaborative and dynamic environment.
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