[Hiring] Global Patient Safety Specialist @LEO Pharma

Role Description

Behind every safety report is a person. Bring your expertise to LEO Pharma and help turn vital safety information into accurate, timely action—with a particular focus on products newly introduced to the market.

Join us in creating a future legacy in medical dermatology. At LEO Pharma, we are global leaders in medical dermatology with 118 years of experience in bringing innovation to healthcare. Each year, close to 100 million people have a better day because of our medicines.

Your role:

• Help ensure that Individual Case Safety Reports (ICSRs) and Adverse Drug Events (ADEs) are processed, distributed and submitted in accordance with applicable local and worldwide requirements.
• Receive and review safety reports and source documents, check completeness, perform triage and duplicate checks, and follow up on critical missing information.
• Accurately enter lower-complexity cases into the safety database, attach relevant documents, and perform MedDRA and WHO Drug Dictionary coding for all cases.
• Write case narratives, establish listedness and causality assessments, and conduct and document follow-up activities.
• Finalize case documentation and prepare, distribute and submit reports within applicable requirements and timelines.
• Follow up on deviations and corrective and preventive actions (CAPAs), supporting their timely closure and compliance with GCP and pharmacovigilance requirements.

Qualifications

• A relevant health science background, with sound knowledge of medical terminology, medicine and pathology.
• A good understanding of case-processing procedures, adverse event documentation practices and distribution methods.
• Strong understanding of EMA, ICH and FDA guidelines and applicable pharmacovigilance requirements.
• Strong computer literacy and knowledge of safety databases, supported by the ability to analyze and interpret data.
• Fluency in English, both written and verbal.

Requirements

• Work with accuracy, integrity and a strong commitment to quality.
• Organized and proactive, with the ability to prioritize competing tasks, anticipate next steps and maintain focus on results.
• Curiosity, sound judgment and confidence in raising concerns.
• Ability to collaborate across cultures and build trusted relationships.

Benefits

• Join a dynamic team dedicated to ensuring the highest standards of drug safety and regulatory compliance.
• Strong focus on collaboration, trust, and mutual respect.
• Opportunity to leverage diverse expertise to drive impactful results.
• Flat organizational structure empowering visible impact and professional growth.
• Valued diversity and recognition of different perspectives, backgrounds, and attitudes.

Company Description

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. Through collaboration and partnerships, we can do much more.

At LEO Pharma, we believe in the power of individuals to drive change. Join our passionate team at LEO Pharma and be yourself as we work together to make a fundamental difference.