Senior Safety Committee Specialist - DSMB

Job Title: Senior Safety Committee Specialist - DSMB Job Location: Remote, North Carolina, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as Senior Safety Committee Specialist – To lead complex safety projects, collaborate with global teams, and ensure the successful implementation of pharmacovigilance practices, contributing to the safety and efficacy of our products. What You’ll Do: Proficient in CEC/DSMB study start-up activities (charter development, member contracting, electronic adjudication system build) and close-out activities. •May act as the company's liaison for CEC/DSMB with the sponsor and assist the company's project teams in executing CEC/DSMB strategies •Work independently to perform day-to-day CEC / DSMB activities through expert knowledge of specialty committee processes and procedures. •Review adjudication/DSMB publications and information sources to keep updated on current regulations, practices, procedures and proposals related to changes in CEC and DSMB practices. •Maintain medical understanding of applicable therapeutic areas and disease states. •Prepare and QCs CEC dossier compilation and submission. •Maintain secure files for DSMB unblinded data. •Assist with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget considerations as they relate to sp