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Senior pharmacovigilance specialist (oña)

Oña
Talent
Publicada el Publicado hace 19 hr horas
Descripción

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

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

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