Drug Safety Specialist

Job Title: Drug Safety Specialist

Location: Madrid, Spain (Full-time, On-site)

Contract: 6-month contract, Start ASAP

Language: Fluent Spanish required

Overview

We are looking for an experienced Drug Safety Specialist (5-10 years in pharmacovigilance) to support our EU QPPV in post-marketing safety activities. This is a 6-month contract role based in Madrid, with an immediate start.

Key Responsibilities

• Oversee pharmacovigilance vendors and partners
• Maintain the Quality Management System (QMS) and Pharmacovigilance System Master File (PSMF)
• Draft and contribute to aggregate safety reports (e.g., PSURs)
• Support local affiliates with PV compliance
• Manage pharmacovigilance agreements (PVAs)
• Work within the Argus safety database

Requirements

• 5-10 years' PV experience, mainly post-marketing
• Strong knowledge of EU PV regulations and GVP
• Fluent in Spanish and proficient in English
• Experience with Argus safety system
• Available to start immediately in Madrid