Tech Specialist - REMOTE
hace 12 días
Girona
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. 𝐄: 𝐌: +44 7547 445433
dermika D.Director/a•Activo hace 3 años
