[Hiring] Senior Drug Safety Pharmacovigilance Specialist & EU-QPPV @TFS HealthScience

Role Description

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.

Benefits

• We provide opportunities for personal and professional growth in a rewarding environment.
• You will join a team that values collaboration, quality, and making a difference in the lives of patients.
• Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture.
• By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence.
• Together, we make a difference.