Global Safety Specialist

Senior Global Safety Specialist 

In Safety, we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.

Join us in creating a future legacy in medical dermatology

At LEO Pharma, we are global leaders in medical dermatology. We have 115 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. 

Your role

You will be responsible for ensure that ICSRs/ADEs with a particular focus on new to market products are processed and distributed/submitted according to local legislations and eventual Safety Data Exchange Agreements and to ensure high compliance is maintained in relation to ICSR legislations worldwide. 

• Receive, review, and ensure completeness of case information and source documents, performing duplicate checks and case triage.
• Accurately enter case data into the database, attach relevant documents, and perform MedDRA and WHO Drug Dictionary coding.
• Write case narratives, assess listedness and causality, and finalize case documentation for distribution/submission.
• Communicate with stakeholders for follow-up information and ensure compliance with follow-up procedures.
• Perform data validation, quality control, and reconciliation of cases, ensuring adherence to source data and procedures.
• Contribute to maintaining a robust medical device adverse event case handling process.
• Manage responsible areas, including new-to-market products and MHRA/EMA download and triage.

Your qualifications

To succeed in this role, we imagine that you have the following qualifications:

• PV experiance - 2 to 5 years
• Strong computer literacy and knowledge of safety databases
• Knowladge and experiance with EMA/ICH/FDA guidelines
• Ability to analyse and interpret data
• Good verbal and written English
• Experiance in case processing procedures
• Strong understanding AE/OE document practices and distribution methods (paper based and software)
• Good knowledge of medicine and pathology to apply in case triage and analysis

Are you our new Safety Specialist? At LEO Pharma, we are committed to helping people achieve healthy skin through pioneering treatments. We invite you to join our Department in Gdańsk, Poland, and be a key player in the Team.

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

Become part of LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. We are 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.

Join us and make an impact in, on and far beyond the skin. Apply now!