OverviewIn 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 products
Lead preparation and management of PSURs, DSURs, aggregate reports, and periodic safety submissions
Support clinical trials through SAE management, reconciliation activities, and safety monitoring
Act as Subject Matter Expert for PSUR and literature review activities
Participate in clinical study teams and collaborate with CROs, affiliates, and external partners




Support pharmacovigilance agreements, regulatory activities, and safety governance processes
Contribute to auditing, inspections, CAPA implementation, and Pharmacovigilance Quality Management System activities
Provide pharmacovigilance training and support to internal teams and vendors
Requisitos principales5+ years of experience in Pharmacovigilance
Strong experience managing PSURs, DSURs, and aggregate safety reporting activities
Experience working with safety databases, MedDRA, and EudraVigilance
Knowledge of pharmacovigilance regulations and quality systems
Excellent communication, stakeholder management, and organizational skills
Fluent English and Spanish
communication
stakeholder management
organizational skills
PSUR/DSUR management
aggregate safety reporting
safety databases

📌 Senior Patient Safety (Barcelona)
🏢 Huxley Associates
📍 Barcelona