Global Safety Specialist

Application deadline:  
Location: Ballerup 2750, , Denmark 
Contract type: Temporary 
Job ID: 2918 

Are you looking for a rewarding opportunity to make a meaningful impact in patient safety? LEO Pharma is seeking a talented Global Safety Specialist to join our Global Safety Operations - Case Management team on a maternity cover basis. In this position, you will play a critical role in ensuring compliance and maintaining high standards in adverse event case management. This is a unique chance to gain valuable experience, contribute to global safety operations, and make a difference in the lives of patients worldwide! 

Your Role 

As a Global Safety Specialist, your focus will be on ensuring the processing and distribution of adverse event cases. You will be responsible for maintaining compliance with local legislations, safety data exchange agreements, and global ICSR regulations. 

Conduct case triage and accurately enter case data into the database. 

• Perform MedDRA and WHO Drug Dictionary coding of all cases. 
• Write case narratives, establish listedness and causality assessments. 
• Communicate with relevant stakeholders for follow-up information. 
• Contribute to maintaining a strong medical device adverse event case handling process. 
• Perform SAE reconciliation with data management/CROs. 
• Act as the Global Safety Operations trial representative. 
• Perform data validation of all cases according to source data. 
• Ensure deviations and CAPAs are followed up on and closed in a timely manner. 
• Establish communication with the PV organization internally and worldwide. 
• Evaluate AEs and OEs received from customer/product complaints. 

Your Qualifications 

• University degree in health or life science with a minimum 2 years of experience in Pharmacovigilance and/or Safety Data Management 
• Strong computer literacy and knowledge of safety databases. 
• Understanding of EMA/ICH/FDA guidelines. 
• Ability to analyze and interpret data. 
• High level of accuracy, integrity, and quality in work practices. 
• Excellent communication skills, both oral and written 

Your New Team 

We are an ambitious team driven by a high level of integrity, science, and passion for our work. We value a great collaborative atmosphere where you can always reach out to a colleague or manager for support and sparring. 

This position is a temporary opportunity (approximately a year), providing you with a unique chance to gain valuable experience and make a significant impact in a short period. While the duration may be temporary, the knowledge and skills you acquire during your time with us will undoubtedly be invaluable for your professional growth. Join our team and seize this exciting opportunity to contribute to our mission and build a strong foundation for your career. 

Contact and Application 

Ready to take the next step in your career and join a company committed to improving the lives of people with skin diseases? Apply now and become a part of our journey to advance dermatology beyond the skin. 

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.