Senior Pharmacovigilance Lead (Remote)

Huxley; 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

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.