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Senior pharmacovigilance specialist

San Sebastián (20080)
QP Group
Publicada el Publicado hace 22 hr horas
Descripción

Senior Pharmacovigilance Specialist

Animal Health / Life Sciences | Europe (Hybrid/On-site)


We are supporting a growing, international life sciences organisation in the search for a Senior Pharmacovigilance Specialist to join their expanding Animal Health division.


This is an opportunity to play a key role in ensuring the safety, compliance, and continuous improvement of pharmacovigilance systems across a portfolio of veterinary medicinal products within a high-growth, innovation-driven environment.


The Role

You will take ownership of core pharmacovigilance activities, ensuring compliance with regulatory requirements and contributing to the ongoing development of robust safety systems.


Key responsibilities include:

* Preparation and submission of Periodic Safety Update Reports (PSURs)
* Supporting regulatory procedures including renewals and variations
* End-to-end adverse event (AE) case management (collection, validation, database entry, assessment, and reporting)
* Contribution to signal detection and benefit-risk evaluation
* Maintenance of the Pharmacovigilance System Master File (PSMF)
* Ensuring accurate recording of safety data within European databases
* Supporting post-authorisation safety studies (PASS)
* Contributing to SOP/WI development and updates
* Supporting audits, CAPAs, KPIs, and continuous improvement initiatives
* Delivering internal pharmacovigilance training where required
* Working closely with the QPPV/Deputy QPPV
* Staying current with evolving regulatory requirements and guidelines


Your Background

We are looking for individuals with:

* A degree in a relevant Life Sciences discipline (e.G. Veterinary Medicine, Pharmacy, Biology, Biotechnology)
* 3–5 years’ experience in Pharmacovigilance, ideally within Animal Health (human PV experience also considered)


Strong knowledge of:

* (V)GVP guidelines
* Case processing within PV databases
* Signal management and/or PSUR preparation
* Fluency in Spanish


Key Skills & Attributes

* Strong attention to detail and scientific rigour
* Ability to operate in regulated, high-responsibility environments
* Analytical mindset with strong problem-solving capability
* Organised, proactive, and able to work autonomously
* Collaborative approach with cross-functional teams


The Opportunity

* Join a fast-growing, internationally active organisation
* Work in a collaborative and innovation-led environment
* Exposure to global pharmacovigilance processes and regulatory frameworks
* Clear opportunities for professional development and progression
* Play a meaningful role in improving animal health and safety outcomes


Reach out to discuss.

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