Global Patient Safety Specialist

LEO Pharma; Gdańsk; On-site; PLN 70,000 - 110,000; Full time

Job summary

LEO Pharma seeks a pharmacovigilance specialist to ensure that individual case safety reports and adverse events are processed, coded, and submitted according to local and global requirements.

You will review reports, perform coding, write narratives, and ensure timely submission while maintaining high quality and regulatory compliance. Strong English and health-science background are essential.

Qualifications

• Background in health sciences with knowledge of medical terminology.
• Experience with case processing and adverse event documentation.
• Familiarity with EMA, ICH and FDA pharmacovigilance guidelines.
• Proficient computer literacy and data analysis.
• Fluency in English (written and spoken).

Responsibilities

• Receive and review safety reports and source documents, check completeness and perform triage.
• Enter lower-complexity cases into the safety database and attach documents.
• Write case narratives and conduct causality assessments.
• Finalize case documentation and submit reports within requirements and timelines.
• Support CAPAs and ensure compliance with GCP and pharmacovigilance requirements.

Skills

Pharmacovigilance expertise

Medical terminology

Data entry accuracy

Analytical thinking

Fluent English

Education

Health sciences background

Tools

Safety databases

MedDRA coding

WHO Drug Dictionary

Job description

Select how often (in days) to receive an alert:

Location:Gdansk80-309,Poland
Contract type:Temporary
Job ID:4986

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. We have 118 years’ experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicines. At LEO Pharma, how we work matters. We build trusted relationships and deliver with impact. We focus on where we can make the greatest difference and have the courage to explore new possibilities. We collaborate across boundaries and take accountability for our part. Here, you can grow, contribute with confidence, and make a meaningful difference together with others.

Your role

You will 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.

To succeed in this role, we imagine that you have the following 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

You work with accuracy, integrity and a strong commitment to quality. Organized and proactive, you can prioritize competing tasks, anticipate next steps and maintain focus on results. Curiosity, sound judgment and confidence in raising concerns will help you succeed, as will an ability to collaborate across cultures and build trusted relationships.

Your new team

You'll be joining a dynamic teamdedicated to ensuring the highest standards of drug safety and regulatory compliance. With a strong focus on collaboration, trust, and mutual respect, our team thrives on leveraging diverse expertise to drive impactful results. Together, we work to navigate complex challenges, deliver meaningful outcomes, and contribute to the success of LEO's therapeutic projects.

Beyond the skin

JBecome 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.