About this role 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. 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 What We
Offer 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.
A Bit More About Us Our journey began over 30 years ago in Sweden,
in the city of Lund. As a full-service global CRO, we build
solution-driven teams working toward a healthier future. Bringing
together over 600 professionals, TFS delivers tailored clinical
research services in more than 50 countries, offering flexible
clinical development and strategic resourcing solutions across key
therapeutic areas including Dermatology, Neuroscience, Oncology,
and Ophthalmology.

📌 Senior Drug Safety Pharmacovigilance SpecialistEU‑QPPV (Madrid)
🏢 TFS HealthScience
📍 Madrid