Buscar empleo: 50 ofertas de trabajo de aemps en Sevilla (mayo 2026)

Freelance Senior Drug Safety Pharmacovigilance Specialist & EU‑QPPV (0.2 FTE)

hace 23 horas

Seville

About this role ¿Listo para inscribirse? Antes de hacerlo, asegúrese de leer todos los detalles pertenecientes a este trabajo en la descripción a continuación. TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. Key Responsibilities EU‑QPPV Responsibilities (≈10 hours/month) • Act as EU Qualified Person for Pharmacovigilance (EU‑QPPV) with ultimate responsibility for the EU Pharmacovigilance System., • Ensure the EU PV System is adequately established, maintained and compliant with applicable GVP modules and EU pharmacovigilance legislation., • Ensure the accuracy, completeness, consistency and continuous availability of the Pharmacovigilance System Master File (PSMF)., • Provide oversight of:, • Safety reporting and ICSR management, • Signal detection and signal management activities, • Risk Management Plans (RMPs) and risk minimization measures, • Act as the primary pharmacovigilance contact with EMA and EU National Competent Authorities (NCAs)., • Lead and support regulatory inspections, audits and compliance activities, including CAPA follow‑up., • Ensure permanent and appropriate EU‑wide pharmacovigilance oversight and governance. Spanish Deputy QPPV Responsibilities (≈5 hours/month) • Act as Deputy Local Qualified Person for Pharmacovigilance (Deputy LQPPV) in Spain., • Support the LQPPV and ensure 24/7 local pharmacovigilance availability for the Spanish Agency of Medicines and Medical Devices (AEMPS)., • Manage and escalate local Spanish safety cases in alignment with national and EU requirements., • Support compliance with Spanish pharmacovigilance legislation and local reporting obligations., • Assist with local pharmacovigilance inspections, audits and regulatory follow‑up activities. Local Literature Monitoring – Spain (≈10 hours/month) • Perform weekly screening of Spanish and local medical and scientific literature., • Identify Individual Case Safety Reports (ICSRs) and potential safety signals., • Ensure findings are reported within regulatory timelines. xcskxlj, • Maintain complete, traceable and inspection‑ready documentation in compliance with GVP requirements. Qualifications • Bachelor’s Degree, preferably in life science or nursing; or equivalent, • 10 years of relevant experience including management of large safety teams, • Able to work in a fast-paced environment with changing priorities, • Understand the medical terminology and science associated with the assigned drugs and therapeutic areas, • Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs, • Ability to work independently as well as in a team matrix organization with little or no supervision, • Excellent written and verbal communication skills, • Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus

Trabajos aemps en SevillaCrear alertas

Búsquedas de empleo más populares en Sevilla

Empleos por barrio

Lugares de trabajo aemps más populares