Pharmacovigilance Safety Specialist

LEO Pharma; Województwo pomorskie; Sur place; PLN 110 000 - 170 000; Temps partiel

Résumé du poste

LEO Pharma in Gdansk seeks a safety professional to ensure ICSRs and ADEs are processed and reported per local and global requirements. You will review reports, code cases, write narratives, and support safety compliance across the pharmacovigilance team.

Join a global leader in medical dermatology known for innovation and a collaborative culture. The role emphasizes accuracy, integrity, and timely communication to maintain high safety standards.

Qualifications

• Relevant health science background with knowledge of medicine and pathology.
• Understanding of case-processing procedures and adverse event documentation.
• Familiarity with EMA, ICH and FDA pharmacovigilance guidelines.
• Ability to analyze and interpret data with safety databases.
• Fluency in English (written and spoken).

Responsabilités

• Receive and review safety reports, check completeness, perform triage and follow up on missing information.
• Enter lower-complexity cases into the safety database and code accordingly (MedDRA/WHO Drug Dictionary).
• Write case narratives, assess listedness and causality, and conduct follow-up activities.
• Finalize case documentation and prepare, distribute and submit reports within timelines.
• Support CAPAs and ensure GCP and pharmacovigilance compliance.

Connaissances

Medical terminology

Case processing procedures

Pharmacovigilance regulations (EMA/ICH

Safety databases

English fluency

Formation

Health sciences degree

Outils

MedDRA coding

WHO Drug Dictionary

Description du poste

LEO Pharma in Gdansk seeks a safety professional to ensure ICSRs and ADEs are processed and reported per local and global requirements. You will review reports, code cases, write narratives, and support safety compliance across the pharmacovigilance team.

Join a global leader in medical dermatology known for innovation and a collaborative culture. The role emphasizes accuracy, integrity, and timely communication to maintain high safety standards.