Drug Safety Officer

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

• Bachelors or Masters 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.

Employment Type : Full Time
Experience: years
Vacancy: 1