Freelance Senior Drug Safety Pharmacovigilance Specialist & …, 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 integral 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. xhfqzwm 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 Postúlate en Kit Empleo: kitempleo.es/empleo/6sa99o