Drug Safety Specialist

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My client is an innovative organization dedicated to developing treatments that address unmet medical needs for individuals, families, and healthcare professionals. With nearly 4,000 professionals across 40+ countries, they are driven by innovation and a commitment to delivering the highest quality care.

As a leader in pharmaceutical research, my client focuses on developing groundbreaking treatments and solutions to improve health and wellbeing worldwide. Their mission is clear: to advance healthcare and support patients through every stage of their lives.

Ready to be a part of something impactful?

What are we looking for?

We are seeking a highly experienced Drug Safety Specialist to join the Pharmacovigilance team at my client's headquarters in Madrid. You will provide vital support to the EU Qualified Person Responsible for Pharmacovigilance (QPPV), ensuring compliance and excellence in drug safety activities throughout the organization.

The challenge:

• Oversee and manage business partners and vendors involved in pharmacovigilance activities.
• Maintain and update the Quality Management System (QMS) and Pharmacovigilance System Master File (PSMF) to ensure regulatory compliance.
• Prepare and contribute to the writing of aggregate safety reports.
• Provide support and guidance to local affiliates on pharmacovigilance requirements and processes.
• Manage Pharmacovigilance Agreements (PVA) contracting and related documentation.

What do you need?

• Languages: Fluent in Spanish and English
• Experience: 5 to 10 years of proven experience in Pharmacovigilance
• Knowledge: Strong understanding of EU pharmacovigilance regulations and guidelines
• Experience managing vendors and business partners within a pharmacovigilance context
• Excellent report writing and communication skills
• Ability to collaborate effectively with cross-functional teams and local affiliates