Drug Safety Officer

TFS HealthScience is a leading global mid-size Contract Research Organization that partners with biotechnology and pharmaceutical companies throughout their clinical development journey. The Drug Safety Officer is responsible for supporting and maintaining local pharmacovigilance activities in compliance with global and local regulatory requirements, ensuring patient safety through effective management of safety information for both marketed products and clinical studies.

Key responsibilities

• Manage local pharmacovigilance activities in accordance with global and local regulatory requirements.
• Support the collection, processing, review, and reporting of 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, and regulatory authorities on safety-related matters.

Requirements

• 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 or CRO industry.
• Good knowledge of EU GVP requirements and pharmacovigilance regulations.
• Experience with adverse event reporting, safety databases, and pharmacovigilance processes.
• Strong communication skills in English and Polish, both written and verbal.

What we offer

• Opportunities for personal and professional growth in a rewarding environment.
• A collaborative team culture that values quality and making a difference in the lives of patients.
• A commitment to core values including Trust, Quality, Passion, Flexibility, and Sustainability.