Senior Safety Advisor

Application deadline:
Location: Gdansk 80-309, , Poland
Contract type: Temporary
Job ID: 4736

Role Description

Help safeguard patients by proactively managing the safety profile of our products in a role where scientific judgment, regulatory understanding, and collaboration come together. As Senior Safety Advisor, you will play an important part in continuous safety surveillance, aggregate reporting, and cross-functional pharmacovigilance activities across our portfolio. This is an opportunity to work in a global environment where your expertise will contribute directly to compliance, patient safety, and informed decision-making.

Your role

As a Senior Safety Advisor, you will proactively manage the safety profile for assigned products and compounds to ensure compliance with pharmacovigilance regulations and guidelines. You will perform safety surveillance activities independently or with limited support, contribute to aggregate reporting and regulatory deliverables, and collaborate with stakeholders across Global Patient Safety, Medical Sciences, Regulatory Affairs, and Medical Affairs. This role combines scientific assessment, regulatory understanding, and operational discipline in a global safety environment.
• Perform continuous safety surveillance activities for assigned marketed products and compounds, including medical assessment of ICSRs and communication of safety issues internally and externally
• Lead Safety Management Teams as required and contribute to cross-departmental teams such as labelling management teams
• Write and review aggregate safety reports, periodic line listings, risk management plans, and safety sections for core safety documents and other relevant reports
• Provide safety input to clinical trial documentation, regulatory responses, submissions, and PV-specific documents
• Contribute to the maintenance of department systems and QMS documents, ensure correct handling of safety data in the safety database, and support the training and mentoring of colleagues

The role offers:

This role offers the opportunity to work broadly across pharmacovigilance activities in a global organization, with exposure to both marketed products and development-related safety deliverables. You will collaborate with expert colleagues across Global Patient Safety and key partner functions, while taking on meaningful responsibility in a role that supports patient safety, regulatory compliance, and continuous improvement.

Your qualifications

To succeed in this role, we imagine that you have the following qualifications:
• University degree in health or biological science, such as MD, MSc, or equivalent
• Minimum 5 years of relevant experience within regulatory affairs, pharmacovigilance, or drug development, including preferably 3 years of safety surveillance experience
• Solid knowledge of global pharmacovigilance regulations and guidelines, including EMA, FDA, and ICH requirements
• Strong scientific and medical understanding, combined with data analysis and interpretation skills
• Fluency in written and spoken English
LEO Pharma is built on collaboration, innovation and curiosity. Is this you? Can you bring this and a high-quality mindset, strong sense of responsibility, and the ability to stay focused, collaborative, and improvement-oriented even when handling complex issues?

Your new team

You will join Global Medical Safety, where the focus is on ensuring robust safety surveillance and regulatory compliance across our product portfolio. The team works closely with colleagues across Global Patient Safety, Medical Sciences, Global Regulatory Affairs, and Global Medical Affairs, and contributes to key cross-functional safety activities and governance forums. As part of a globally connected organization with Danish roots, you will collaborate broadly while being based in Gdańsk.

Your 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. Please refrain from adding a photo to your CV.

Beyond the skin

Become part of LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. We are the legacy-builders of the future - enabling people to have a better today and tomorrow. With the world as our lab, we are transforming innovative ideas into more effective and easier-to-use medicines. Through collaboration and partnerships, we can do much more.

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 fundamental difference.

For certain positions, LEO Pharma might complete a background check conducted by a third party.

Join us and make an impact in, on and far beyond the skin. Apply now!

Report a concern: Whistleblower hotline | LEO Pharma