Senior Safety Officer (to be assigned as Country Safety Head in Hungary)

Description

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Global Safety. You will play a critical part in driving innovation and making an impact in the Safety space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main responsibilities :

• Accountable for Pharmacovigilance in the assigned country and acts as the main PV contact for local authorities.
• Serves as local Responsible Person for Pharmacovigilance (RPP/QPPV) and ensures inspection readiness.
• Leads all country-level PV activities: case management, safety surveillance, signal detection, risk management, and mitigation.
• Ensures compliance with global, regional, and local PV regulations and policies.
• Establishes and maintains robust local PV systems, procedures, tools, and training.
• Builds strong collaboration with in-country functions (Medical, Regulatory, Quality, Commercial, Legal).
• Represents PV locally, coordinates with internal and external PV vendors, and supports global PV partnerships.
• Oversees safety data flow, literature screening, local Risk Management Plans (RMPs), and safety alerts.
• Guarantees audit/inspection readiness, maintains the local PV Master File, and ensures quality documentation.
• Contributes to local and global PV initiatives, including periodic safety reports and patient support programs.

Requirements

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique

• Education: Degree in Life Sciences, Pharmacy, Medicine, or a related field.

• Languages: Fluency in Hungarian (ideally a native speaker) and English, both written and spoken, is required.

• Experience: Minimum of 5 years in pharmacovigilance; prior experience in a similar role is considered a strong asset.

• Skills: In-depth knowledge of local and global PV regulations; proven experience with audits, inspections, and vendor management. Excellent organizational and leadership abilities combined with strong communication skills to collaborate effectively across cross-functional teams.

Benefits

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.