Senior Pharmacovigilance Associate

Bucharest, Bucharest, ro💼 Full-time🗓 2026-09-15 → 2026-09-26

Core

Managing Individual Case Safety Reports (ICSRs) and Safety Signal Detection within a global pharmacovigilance unit, ensuring compliance with regulations and client requirements.

Role type

Senior IC pharmacovigilance associate (ICSR management & local contact)

Builds

Monthly safety reports for clients and regulatory submissions

Domain

Life sciences / Pharmacovigilance

Deliverable

client delivery

Required skills

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

Preferred skills

LCPPV/PRLS role execution, medical information interaction, quality complaint handling

Technologies

PrimeVigilance, MS Office

Responsibilities

Processing ICSRs from all sources, performing ICSR follow-up, managing SAE/SUSARs (unblinding, protocol review), handling product quality complaints, generating database outputs and reports, acting as Local Contact Person (LCPPV) and Person Responsible for Local Screening (PRLS)

Seniority

Senior, hands-on IC

Sourced via smartrecruiters · Listed on CareerPlan, which tracks 70,000+ jobs from 20+ sources.

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.