Dermatology Pharmacovigilance 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

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.