Freelance Senior Drug Safety Pharmacovigilance Specialist&EU …, Ceuta

About this role

La información a continuación detalla los requisitos del puesto, la experiencia esperada del candidato y las cualificaciones correspondientes. 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 measuresAct 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. xiphteb 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 . Maintain complete, traceable and inspection‐ready documentation in compliance with GVP requirements. Qualifications Bachelor's Degree, preferably in life science or nursing; or equivalent10 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 SOPsAbility 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