Safety Lead
Application deadline: 23-Nov-2025
Location: Ballerup 2750, , Denmark
Contract type: Permanent
Job ID: 3890
Are you ready to lead global safety strategies for a groundbreaking new treatment in the rare disease area? Do you thrive in a dynamic environment where flexibility and adaptability are key to success? Would you like to drive development and post-market safety activities in a collaborative, international team?
Join us in shaping the future of medical dermatology
At LEO Pharma, we are global leaders in medical dermatology, with 115 years’ experience in bringing innovation to healthcare. Each year, close to 100 million people benefit from our medicines. In Global Safety Surveillance, we embrace a “challenge accepted” mindset and winning behaviours of simplification, collaboration and accountability.
Your Role
We are seeking a Safety Lead to join LEO Pharma’s Global Safety Surveillance (GSS) department in Ballerup. This is a unique opportunity to take the safety lead role on a newly acquired rare disease compound, guiding its development and ensuring compliance with global pharmacovigilance regulations. You’ll be at the forefront of safety strategy definition and risk management, lead cross-functional teams and ensure high standards in medical and scientific integrity.
Your key responsibilities
- Oversee and lead global safety risk management strategies for the assigned product(s), including continuous surveillance, proactive signal detection and risk communication
- Develop and implement comprehensive safety strategies throughout clinical development and post-marketing
- Provide the strategic/medical direction for periodic reports including review and approval including being a key contributing author for documents describing the benefit risk of assigned product(s)
- Lead the safety contribution for clinical development including providing clinical safety input to design, conduct, data analysis and interpretation
- Lead the development and implementation of signal management activities
- Lead the cross-functional Safety Committee
- Represent Global Safety in strategic projects and in interactions with internal and external business partners, Regulatory Authorities, DMC ( Data Monitoring Committee)
- Act as a key safety and pharmacovigilance SME, contributing to CTD submissions, regulatory interactions, clinical safety strategy, TPP, and maintenance of RSI, IB, and CCSI.
Your qualifications
To succeed in the role you meet the following qualifications:
- Higher level biomedical or scientific qualification (e.g.. MD, DVM or PhD)
- Solid experience and knowledge in drug development and drug safety, with proven leadership in safety risk management (10 + years’ pharma experience within safety and pharmacovigilance and drug development)
- Profound knowledge and understanding of medical concepts, disease processes and scientific methodology
- Solid and comprehensive understanding of global (EMA/FDA/ICH) regulatory requirements
- Experience in leading global cross-functional product safety committee, driving medical safety strategy across case review, signal detection, reporting, and risk management
- Excellent assertive communication skills with the ability to communicate complex medical and scientific topics with clarity and authority
- Strong strategic and scientific mindset, project management skills, and ability to handle dynamic workloads and change.
- Fluent in spoken and written English, with advanced stakeholder management capabilities.
About your team
Global Safety Surveillance consists of approx. 20 employees, divided in three teams. Two teams are based in Ballerup and one team in Poland.
You’ll be based in Denmark focusing primarily on drug development activities, Our culture is built on expertise, collaboration, and adaptability — where every member plays a vital role in improving patient care.
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.
Report a concern: Whistleblower hotline | LEO Pharma