Senior Patient Safety

Huxley Associates; Madrid; Remote; EUR 70,000 - 100,000; Full time

Job summary

Huxley is seeking two senior Pharmacovigilance professionals to join the Corporate Patient Safety function. You will support strategic pharmacovigilance activities across clinical development and marketed products, driving PSURs, DSURs, and safety reporting.

You will interact with CROs, affiliates, and external partners to ensure compliance. You will oversee safety governance, auditing, and CAPA activities, and provide PV training to internal teams and vendors.

Qualifications

• 5+ years of experience in Pharmacovigilance.
• Experience in PSURs/DSURs and aggregate safety reporting.
• Experience with safety databases, MedDRA and EudraVigilance.
• Knowledge of PV regulations and quality systems.
• Excellent communication and stakeholder management.

Responsibilities

• Manage corporate pharmacovigilance activities for marketed and investigational products.
• Lead PSURs, DSURs, and other periodic safety submissions.
• Support clinical trials through SAE management and safety monitoring.
• As SME for PSUR and literature review activities.
• Collaborate with CROs, affiliates, and external partners.
• Support pharmacovigilance agreements, regulatory activities, and safety governance.
• Contribute to auditing, inspections, CAPA, and PV QMS activities.
• Provide pharmacovigilance training and support to internal teams and vendors.

Skills

Pharmacovigilance

PSUR/DSUR management

Safety reporting

MedDRA/EudraVigilance

Regulatory knowledge

Stakeholder management

English

Spanish

Vendor coordination

Education

Degree in Life Sciences / Pharmacy / Biomedical Sciences / Medicine

Tools

MedDRA

EudraVigilance

Job description

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