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.

Responsabilidades Manage 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 principales 5+ 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