Senior Drug Safety Pharmacovigilance Specialist & EUQPPV

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

EUQPPV Responsibilities (10 hours/month)

• Act as EU Qualified Person for Pharmacovigilance (EUQPPV) 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 followup.

• Ensure permanent and appropriate EUwide 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 followup 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 inspectionready documentation in compliance with GVP requirements.

Qualifications

• Bachelors 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.