Descripción de la oferta
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 #J-18808-Ljbffr
