About this role 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. • 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