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 Provider (FSP) solutions.

The Drug Safety officer is responsible for supporting and maintaining local pharmacovigilance activities in compliance with global, regional, and local regulatory requirements. The role involves ensuring patient safety through effective management of safety information for both marketed products and clinical studies while serving as a key local pharmacovigilance contact.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a integral pharmaceutical company that is an industry leader within its therapeutic area.

Key Responsibilities

Manage local pharmacovigilance activities in accordance with global and local regulatory requirements.
Support the collection, processing, review, and reporting of adverse events, serious adverse events,



and other safety information.
Ensure timely submission of safety reports and maintenance of local pharmacovigilance documentation.
Support inspections, audits, and CAPA activities to ensure ongoing compliance.
Collaborate with internal stakeholders, healthcare professionals, regulatory authorities, and external partners on safety-related matters.
Contribute to pharmacovigilance training, process improvements, and compliance initiatives.
Support safety activities related to both marketed products and clinical studies.

Qualifications

Bachelor's or Master's degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related scientific discipline.
Relevant experience in Pharmacovigilance, Drug Safety, or Clinical Safety within the pharmaceutical, biotechnology, or CRO industry.
Good knowledge of EU GVP requirements and pharmacovigilance regulations.
Experience with adverse event reporting, safety databas

📌 Drug Safety Officer (Barcelona)
🏢 TFS HealthScience
📍 Barcelona