Safety Advisor, Global Medical Safety

Application deadline:  
Location: Ballerup 2750, Denmark, Denmark 
Contract type: Temporary 
Job ID: 4657 

Take a leading role in shaping the safety profile of medicines for LEO Pharma products worldwide.

At LEO Pharma, we are driven by a clear purpose: to advance the standard of care for people living with skin diseases and other serious conditions. As our new Senior Safety Advisor in Global Medical Safety, you will play a key role in safeguarding patients by proactively managing the safety profile of assigned marketed products and compounds.

Your role

As Safety Advisor in Global Medical Safety, you will proactively manage the safety profile of assigned products and compounds. You will ensure continuous safety surveillance, support regulatory compliance, and provide high-quality medical and scientific input to key safety documents and decisions. This is a role with broad impact across pharmacovigilance, regulatory interactions, and cross-functional collaboration.

• Perform safety surveillance activities for assigned marketed products and compounds.
• Conduct medical assessments of individual case safety reports.
• Provide input to aggregate safety reports, periodic line listings, risk management plans, and safety sections for key regulatory documents and responses to Health Authorities.

You will also provide input to clinical trial documents such as protocols, informed consent forms, and safety data management plans when CROs are involved in handling safety data. In addition, you will contribute to quality management systems, ensure correct handling of safety data in the safety database, communicate safety issues internally and externally. 

Your qualifications

We are looking for a scientifically strong and quality-driven professional with experience in pharmacovigilance, regulatory affairs, or drug development. The most critical competencies for this role include safetysurveillance expertise, data analysis and interpretation, regulatory knowledge, high-quality medical writing, and the ability to work across the drug safety value chain. 

• University degree in health or biological science, such as MD, MSc, or equivalent.
• Minimum 5 years of relevant experience within pharmacovigilance, regulatory affairs, drug development, or a related area.
• Some years of experience with safety surveillance.
• Knowledge of global regulatory requirements, including EMA, FDA, and ICH guidelines
• Fluent written and spoken English.

As a person, you are collaborative, structured, and quality-focused. You take action on important issues, communicate clearly with stakeholders, and remain focused on delivering results even when facing complex challenges or changing priorities.

Your new team

You will join Global Medical Safety, part of LEO Pharma’s Global Patient Safety organisation. The team works closely with colleagues across Medical Sciences, Global Regulatory Affairs, Global Medical Affairs, and other safety functions. You will become part of a professional and supportive environment where knowledge-sharing, trust, and collaboration are central to how we work. Your expertise will help inform important decisions and support the safe use of LEO Pharma products globally.

Contact and application

For additional information, please contact Claudia Pierleoni-Nielsen, Senior Director Head of Global Medical Safety, clpir@leo-pharma.com

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.

Due to summer vacation the recruitment process may take longer than usual. 

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.
 
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