Drug Safety Officer

TFS HealthScience; Kraków; On-site; PLN 90,000 - 130,000; Full time

Job summary

TFS HealthScience is seeking a Drug Safety Officer in Kraków to support and maintain local pharmacovigilance activities in accordance with EU GVP and local regulations, ensuring patient safety across marketed products and clinical studies.

You will collaborate with internal stakeholders, regulatory authorities, and external partners on safety matters, manage adverse event reporting and PV documentation, and assist with inspections, CAPA, and process improvements.

Qualifications

• Bachelor's or Master's in Life Sciences or related field.
• Experience in Pharmacovigilance, Drug Safety, or Clinical Safety.
• Knowledge of EU GVP and pharmacovigilance regulations.
• Experience with adverse event reporting and safety databases.
• Strong English communication.

Responsibilities

• Manage local pharmacovigilance activities per global and local regulatory requirements.
• Support collection, processing, review, and reporting of adverse events and other safety information.
• Ensure timely submission of safety reports and maintenance of local PV documentation.
• Support inspections, audits, and CAPA activities to ensure compliance.
• Collaborate with internal stakeholders, healthcare professionals, regulatory authorities, and external partners on safety matters.
• Contribute to PV training, process improvements, and compliance initiatives.
• Support safety activities for marketed products and clinical studies.

Skills

Strong communication skills in English

Excellent organizational skills

Ability to work independently

Education

Bachelor's or Master's degree in Life Sciences, Pharmacy, Medicine, Nursing, or related field

Tools

Pharmacovigilance systems (safety databases)

Job description

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
• 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

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.

TFS HealthScience is a global, mid-sized contract research organization (CRO) partnering with biotechnology and pharmaceutical companies across the full clinical development lifecycle. Our expertise spans full-service clinical development, project-based support, strategic resourcing, and Functional Service Provider (FSP) solutions, matching experienced professionals to roles where they deliver the greatest impact.