PV Officer

Ergomed

Bucharest, Bucharest, ro💼 Full-time🗓 2026-08-19 → 2026-09-25

Core

Managing Individual Case Safety Reports (ICSRs) and Safety Signal Management for pharmaceutical clients.

Role type

Pharmacovigilance Officer (ICSR Management)

Builds

ICSR databases, safety reports, and regulatory submissions for pharmaceutical partners.

Domain

Life Sciences / Pharmacovigilance

Deliverable

production ML models | product features | dashboards & analysis | client delivery

Required skills

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

Preferred skills

LCPPV/PRLS role experience, RA & PV network support

Technologies

PrimeVigilance platform, MS Office

Responsibilities

Processing ICSRs from all sources, performing ICSR follow-up, managing SAE/SUSARs (unblinding, reconciliation), handling product quality complaints, generating database outputs and monthly client reports, mentoring junior employees, acting as Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS).

Seniority

Junior to Mid-level, 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.