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Job DescriptionJob Summary:The Clinical Safety Specialist is responsible for delivering high quality and compliant Clinical Safety management for clinical studies e.g., EFS/FIH, IDE, Post-Market sponsored by the BD Peripheral Intervention business unit to ensure they meet the highest standards for scientific quality, integrity and ethics and are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations.Key Job Responsibilities:Provide Clinical Safety Management support for BDPI clinical studies to enable successful completion of study objectives and deliverables. Ensure quality and compliance for safety-related activities performed for assigned clinical studies.Conduct Clinical Safety monitoring activities for assigned clinical studies to proactively identify/review/track reportable safety events, identify safety event trends/signals, issue and address data queries, ensure timely reporting for reportable safety events e.g., Unanticipated Adverse Device Effects, device deficiencies, etc., address/escalate safety non-compliance issues, and verify that any corrective actions are implemented.Serve as the Clinical Safety expert and resource for BD stakeholders, Investigators, and study site personnel for assigned clinical studies. Develop and maintain strong relationships with investigational site staff, HCP consultants e.g., Medical Monitors, CEC/DMC members, and cross-functional study teams to support Clinical Safety deliv
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