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