Drug Safety Officer (Pharmacovigilance)
TFS HealthScience · Warszawa
Job description
About the role
TFS HealthScience is a global mid-size Contract Research Organization partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. Its Drug Safety Officer supports and maintains local pharmacovigilance activities in line with global, regional and local regulatory requirements, ensuring patient safety through the management of safety information for marketed products and clinical studies. The role is a key local pharmacovigilance contact within the SRS/FSP team, dedicated to one sponsor, a global pharmaceutical company.
Key responsibilities
- Manage local pharmacovigilance activities according to 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 maintain compliance.
- Collaborate with internal stakeholders, healthcare professionals, regulatory authorities and external partners on safety matters.
- Contribute to pharmacovigilance training, process improvements and compliance initiatives.
- Support safety activities for both marketed products and clinical studies.
Required profile
- 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 English communication skills.
- Organised, able to work independently and manage multiple priorities.
What we offer
- A competitive salary aligned with local market conditions, based on experience and qualifications, plus applicable benefits.
- Opportunities for personal and professional growth in a collaborative, quality-focused environment.
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Published 1 day ago
Expires 1 month from now
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TFS HealthScience
Warszawa
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