Documentation Associate Specialist in Global Safety

Field of work:  Clinical Development
Posting Date:  7 Nov 2024

Application deadline:  
Location: Gdansk 80-309, , Poland 
Contract type: Permanent 
Job ID: 2674 

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Role Description

Are you a detail-oriented professional with a passion for ensuring patient safety through meticulous document management and safety reporting? Do you thrive in a collaborative environment where your expertise can support global safety initiatives? At LEO Pharma, we are committed to helping people achieve healthy skin through innovative treatments. We invite you to join our Global Safety Surveillance (GSS) team in Gdańsk, where you will play a crucial role in managing and coordinating safety documentation and supporting our safety surveillance efforts. 

 

Shape the LEO Pharma of tomorrow   

At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a difference, this role is your gateway to a world of opportunities! 

 

Your Role: 

 

As an Associate Documentation Specialist, you will perform document management as well as technical and administrative support for a variety of safety surveillance documents. Your key responsibilities will include: 

 

  • Perform document management and coordination of safety reports such as PSURs, Risk Management Plans, and associated documents for all LEO products. 
  • Gather data and generate/reconcile line listings, tabulations, and other queries for periodic and ad-hoc reports. 
  • Liaise with GSS Safety Advisors and other safety report contributors to gather content, receive information, and obtain approvals of reports. 
  • Perform technical quality control of documents incl. formatting, crosslinking etc. 
  • Ensure correct archiving of all GSS reports and related documents in the electronic document management system. 
  • Support administrative routines regarding the signal detection and management process. 
  • Participate in the maintenance and development of department systems and digital solutions. 

 

Your Qualifications 

To excel in this role, you will need: 

 

  • Experience with document management and the value of correct archiving and metadata compliance. 
  • Great IT skills and tech-savviness. 
  • Experienced user of Microsoft Word and preferably also Excel. 
  • Demonstrating meticulous attention to detail in all aspects of your work. 
  • Fluent verbal and written English. 

 

Your New Team 

 

You will join a dedicated group of professionals committed to ensuring our safety surveillance processes are efficient, compliant, and effective. You will collaborate closely with various internal departments and external partners. Our team values open communication, collaboration, and a shared commitment to excellence, continually pushing the boundaries to deliver innovative safety solutions. 

 

Contact and Application 

 

Ready to take the next step in your career? Apply now to join LEO Pharma. We look forward to receiving your application! 

At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities. 

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.  
 

Beyond the skin

 

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. 
 
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 difference.
 
For certain positions, LEO Pharma might complete a background check conducted by a third party.

 

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