Drug Safety Officer
About this role
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 global 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 databases, and pharmacovigilance processes.
Strong communication skills in English and Polish, both written and verbal.
Excellent organizational skills with the ability to work independently and manage multiple priorities.
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.
EU Pay Transparency
Poland
Salary: Competitive and aligned with local market conditions, based on experience and qualifications, plus applicable benefits.
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.
Originally posted on Himalayas