Drug Safety Advisor

Application deadline:  
Location: Gdansk 80-309, , Poland 
Contract type: Permanent 
Job ID: 2919 

Are you ready to take your career to the next level and develop in a role that will allow you to manage the global safety profile for post marketed products?
 
LEO Pharma has embarked on an ambitious journey to become the preferred dermatology care partner improving people’s lives around the world – and that is why we need you. 
 
Your role
 
Your overall objective will be to ensure continuous safety surveillance of marketed compounds/products. 
 
Your main tasks will be to:
•    Provide overall safety surveillance for assigned products, on an on-going basis
•    Conduct medical evaluation/review of Adverse Events reports, Summary of Product Characteristics, Company Core Safety Information (CCSI), Patient Information Leaflets and other safety information
•    Perform signal detection for assigned products
•    Write and review aggregated safety reports, Risk Management Plans (RMPs), safety sections required in documents such as CCSI/core SmPC and other relevant safety reports
•    Prepare PV specific documents for regulatory submissions
 
Your qualifications 
 
To succeed in this role, we imagine that you have the following qualifications:
 
•    University degree in health or biological science (MD, MSc, MSc Pharm, or equivalent 
•    Preferably 1-3 years of experience working in an international organization, in PV, RA or drug development
•    Knowledge of medical and disease concepts
•    Stakeholder and quality-oriented mindset
•    Medical and scientific writing skills 
•    Fluent verbal and written English
•    Strong data analysis and interpretation skills
 
Your new team
 
You will join Global Safety Surveillance which consists of 3 teams working with products in all phases of the drug life cycle and striving to safeguard our patients’safety.
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.
 
Contact and 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.
 

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.