Overview In this role you support the handling of SAEs and adverse events in clinical trials and market reports, ensuring accurate data capture in safety systems. You will work within the SRS/FSP team dedicated to a sponsor, contributing to pharmacovigilance processes and regulatory compliance. Your work includes case reviews, narrative drafting, coding of events, and assisting with SAE reconciliation and EudraVigilance registration. The position emphasizes collaboration across project teams, maintaining up-to-date knowledge of safety regulations, and improving established safety routines.

ResponsabilidadesSupport SAE handling in clinical trials and market reports under SOPs and regulatory requirementsReview cases and draft AE/SAE narratives as neededCode adverse events,



medical history and concomitant medicationsAssist SAE reconciliation and data handling (DCF)Support EudraVigilance registration and related mattersParticipate in project groups and cross-departmental meetingsUpdate safety handling templates per SOPs and study needsContribute to developing routines to improve safety work processesStay informed on laws, directives, and guidelines for SAE handling and pharmacovigilance Requisitos principalesBachelor’s degree in life science or nursing or equivalentAbility to work in a fast-paced environment with changing prioritiesUnderstanding of medical terminology and drugs/therapeutic areasBasic knowledge of GCP, ICH guidelines, pharmacovigilance legislation, and SOPsAbility to work independently and in a matrix team structureExcellent written and verbal communicationProficiency with word processing; spreadsheets desirablestrong communication skillsteam collaborationattention to detailpharmacovigilance knowledgecase coding of adverse eventsSAE reconciliation

📌 Drug Safety Associate (Barcelona)
🏢 Jobrapido
📍 Barcelona