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Medical Safety Specialist

Krish SharmaUnited StatesMIDPosted 10d ago
Clinical Trial SafetyAdverse EventsSerious Adverse EventsGCPRegulatory DocumentationMedical NarrativesSafety Data ReconciliationCRO ManagementMedidata RAVE
About the Role We are seeking a Medical Safety Specialist with hands-on clinical trial safety experience to support medical-device clinical studies. This role involves reviewing and documenting adverse events, supporting clinical safety assessments, and preparing safety reports. Key Responsibilities • Review, document, and follow up on Adverse Events (AEs), Serious Adverse Events (SAEs), and device deficiencies • Support clinical safety assessments, reporting, and safety-data reconciliation • Prepare safety reports, medical narratives, safety summaries, and regulatory documentation • Maintain GCP compliance and inspection-ready documentation Requirements • Bachelor's degree in Life Sciences, Nursing, Biomedical Sciences, or Healthcare • 3+ years of safety experience, including clinical trial safety • Experience with AE/SAE processing, safety documentation, and CRO management • Knowledge of GCP and US/international regulations for pre-market and post-market clinical studies

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