Overview In this role you support corporate pharmacovigilance across marketed and investigational products, ensuring safety governance and regulatory compliance. You will lead safety submissions and collaborate with CROs, affiliates, and external partners to drive safety outcomes. You contribute to audits, CAPAs, and PV training, shaping the safety strategy within a integral team. This position offers hands-on management of PSUR/DSUR activities and close involvement with clinical development and post-market safety.

ResponsabilidadesManage corporate pharmacovigilance activities for marketed and investigational productsLead preparation and management of PSURs, DSURs, aggregate reports, and periodic safety submissionsSupport clinical trials through SAE management, reconciliation activities, and safety monitoringAct as Subject Matter Expert for PSUR and literature review activitiesParticipate in clinical study teams and collaborate with CROs, affiliates,



and external partnersSupport pharmacovigilance agreements, regulatory activities, and safety governance processesContribute to auditing, inspections, CAPA implementation, and Pharmacovigilance Quality Management System activitiesProvide pharmacovigilance training and support to internal teams and vendors Requisitos principales5+ years of experience in PharmacovigilanceStrong experience managing PSURs, DSURs, and aggregate safety reporting activitiesExperience working with safety databases, MedDRA, and EudraVigilanceKnowledge of pharmacovigilance regulations and quality systemsExcellent communication, stakeholder management, and organizational skillsFluent English and Spanishcommunicationstakeholder managementorganizational skillsPSUR/DSUR managementaggregate safety reportingsafety databases

📌 Senior Patient Safety - barcelona
🏢 Jobrapido
📍 Barcelona