Drug Safety Officer

🔥 4 minutes ago

🇵🇱 Poland – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

👻 Ghost score 10%

infoinfo

🗣️🇵🇱 Polish Required

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Logo of TFS HealthScience - Contract Research Organization

TFS HealthScience - Contract Research Organization

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• 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 • 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 for marketed products and clinical studies • Serve as a key local pharmacovigilance contact dedicated to one global pharmaceutical sponsor

🎯 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 written and verbal communication skills in English and Polish • Excellent organizational skills • Ability to work independently and manage multiple priorities

🏖️ Benefits

• Opportunities for personal and professional growth • Collaborative, quality-focused, and rewarding work environment • Applicable benefits in line with local market conditions

Apply Now

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