Senior Pharmacovigilance Associate

Kraków, Lesser Poland Voivodeship, pl💼 Full-time🗓 2026-09-15 → 2026-09-25

Core

Managing Individual Case Safety Reports (ICSRs) and SAE/SUSARs within the ICSR management unit, ensuring compliance with regulations and client requirements.

Role type

Senior Pharmacovigilance Associate (ICSR Management)

Builds

Monthly safety reports and database outputs for clients

Domain

Life Sciences / Pharmacovigilance

Deliverable

client delivery

Required skills

ICSR processing, SAE/SUSAR management, MedDRA and WHO coding, reconciliation, data protection, workflow management

Preferred skills

LCPPV (Local Contact Person for Pharmacovigilance) role, PRLS (Person Responsible for Local Screening) role

Technologies

MS Office

Responsibilities

Processing ICSRs from all sources, performing ICSR follow-up, managing SAE/SUSARs (unblinding, trial reconciliation, protocol review), handling product quality complaints, interacting with Medical Information, generating database outputs and reports, managing workflow and resources, acting as LCPPV and PRLS for designated countries/languages

Seniority

Senior, hands-on IC

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About Ergomed

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.