Senior Patient Safety Madrid, Kingdom Of Spain, ES For one of our key clients in the pharmaceutical industry, we are looking for two experienced professionals to join the Corporate Patient Safety function and support strategic pharmacovigilance activities across clinical development and marketed products.

Key Responsibilities

Manage corporate pharmacovigilance activities for marketed and investigational products.

Lead the preparation and management of PSURs, DSURs, aggregate reports, and other 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.

Required Skills

Degree in Life Sciences, Pharmacy, Biomedical Sciences, Medicine, or related field.

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.

Nice to HavePrevious experience in Clinical Development environments.

Experience supporting audits and health authority inspections.

Expertise in Pharmacovigilance Quality Management Systems.

Experience coordinating external vendors, affiliates, and CROs.

Position Details

Start Date: ASAP

Location: 100% Remote

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📌 Senior Patient Safety (Cárcer)
🏢 Huxley
📍 Cárcer