Sr/Safety Operations Specialist

**Job Overview****Essential Functions**- Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.- Perform pharmacovigilance activities, including collecting and tracking incoming adverse events (AEs) and endpoint information.- Determine initial/update status of incoming events, database entry, coding AEs and products, writing narratives, and performing literature-related activities.- Conduct quality reviews, assist with reconciliation, case closure activities, and coordinate translations as per project timelines.- Assess safety data for reportability to relevant authorities and track/report cases to regulatory bodies, ethics committees, and other oversight groups.- Contribute to or lead deliverables in safety publishing, risk management, safety surveillance, and medical information.- Ensure compliance with all project-related processes and activities, meeting quality, productivity, and delivery standards.- Build a positive, collaborative team environment, providing training and mentoring for less experienced team members and operations staff.**Qualifications**- Bachelor's degree in a scientific or healthcare discipline, or allied life sciences.- At least 1 year in pharmacovigilance.- ** Experience with case processing in Argus for clinical trial studies preferred.**- Advanced level of English- Excellent knowledge of medical terminology and applicable safety databases.- Strong organizational skills, attention to detail, and the ability to manage multiple tasks and deadlines.LI-Remote