Drug Safety Officer

TFS HealthScience

2d

About The Position

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 global pharmaceutical company that is an industry leader within its therapeutic area.

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, biotechnology, 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
• Excellent organizational skills with the ability to work independently and manage multiple priorities.

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.

Benefits

• Opportunities for personal and professional growth
• Rewarding environment
• Team that values collaboration, quality, and making a difference in the lives of patients
• Competitive salary and applicable benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level