In this role you safeguard patient safety by coordinating pharmacovigilance across clinical development and post-marketing activities. You will collaborate with general teams to ensure regulatory compliance and robust safety monitoring. You provide operational and medical input for trials, safety reports, and submissions, while leading safety planning and medical reviews. Your work drives risk assessment and data-driven decisions to protect patients and support product safety strategy.Provide operational and medical support to clinical trials, including SAE management, medical review, reconciliation, unblinding, and safety monitoringLead preparation and medical input for aggregate safety reports (DSURs) and periodic regulatory submissionsReview safety-related sections of clinical documents (protocol synopses, Data Management Plans, Safety Topics of Interest)Act as medical lead for the development of Safety Reporting PlansParticipate in clinical study team meetings,



including CRO collaborationSupport non-interventional studies, market research, and registries (ICSR management and safety monitoring)Conduct post-marketing safety surveillance, including medical review of dataSupport the Patient Safety Director and EU QPPV in regulatory dutiesContribute to Pharmacovigilance Quality Management System and implementation of proceduresPerform safety database tasks and signal detection as medical writer or reviewerReview PSURs and Risk Management PlansPostgraduate training in pharmacovigilance, clinical safety, or epidemiology (preferred)Experience in pharmacovigilance or clinical safety in a corporate setting (valued)Proficiency in safety databasesStrong understanding of GVPs and regulatory frameworksCross-functional collaborationEffective communication with internal teams and CROsSafety databases proficiencyICSR managementDSUR and PSUR review

📌 Patient Safety Senior Manager (Barcelona)
🏢 Almirall
📍 Barcelona