Gdansk Global Patient Safety Specialist 80 309

Job description

Behind every safety report is a person. Bring your expertise to LEO Pharma and help turn vital safety information into accurate, timely action—with a particular focus on products newly introduced to the market. Join us in creating a future legacy in medical dermatology At LEO Pharma, we are global leaders in medical dermatology. We have 118 years’ experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicines. At LEO Pharma, how we work matters. We build trusted relationships and deliver with impact. We focus on where we can make the greatest difference and have the courage to explore new possibilities. We collaborate across boundaries and take accountability for our part. Here, you can grow, contribute with confidence, and make a meaningful difference together with others. Your role You will help ensure that Individual Case Safety Reports (ICSRs) and Adverse Drug Events (ADEs) are processed, distributed and submitted in accordance with applicable local and worldwide requirements. Receive and review safety reports and source documents, check completeness, perform triage and duplicate checks, and follow up on critical missing information. Accurately enter lower-complexity cases into the safety database, attach relevant documents, and perform MedDRA and WHO Drug Dictionary coding for all cases. Write case narratives, establish listedness and causality assessments, and conduct and document follow-up activities. Finalize case documentation and prepare, distribute and submit reports within applicable requirements and timelines. Follow up on deviations and corrective and preventive actions (CAPAs), supporting their timely closure and compliance with GCP and pharmacovigilance requirements. Your qualifications To succeed in this role, we imagine that you have the following qualifications: A relevant health science background, with sound knowledge of medical terminology, medicine and pathology. A good understanding of case-processing procedures, adverse event documentation practices and distribution methods. Strong understanding of EMA, ICH and FDA guidelines and applicable pharmacovigilance requirements. Strong computer literacy and knowledge of safety databases, supported by the ability to analyze and interpret data. Fluency in English, both written and verbal You work with accuracy, integrity and a strong commitment to quality. Organized and proactive, you can prioritize competing tasks, anticipate next steps and maintain focus on results. Curiosity, sound judgment and confidence in raising concerns will help you succeed, as will an ability to collaborate across cultures and build trusted relationships. Your new team You'll be joining a dynamic team dedicated to ensuring the highest standards of drug safety and regulatory compliance. With a strong focus on collaboration, trust, and mutual respect, our team thrives on leveraging diverse expertise to drive impactful results. Together, we work to navigate complex challenges, deliver meaningful outcomes, and contribute to the success of LEO's therapeutic projects. Your application You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest. Please refrain from adding a photo to your CV. Beyond the skin JBecome part of LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. We are the legacy-builders of the future – enabling people to have a better today and tomorrow. With the world as our lab, we are transforming innovative ideas into more effective and easier-to-use medicines. Through collaboration and partnerships, we can do much more. At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a fundamental difference. For certain positions, LEO Pharma might complete a background check conducted by a third party. Report a concern: Whistleblower hotline | LEO Pharma #LI-Remote Apply now » Find similar jobs: Opens in a new tab. Opens in a new tab. Opens in a new tab. Opens in a new tab. ©2024 LEO Pharma. All rights reserved. Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. 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