Pharmacovigilance Associate

Tokyo, Tokyo, jp💼 Full-time🗓 2026-09-09 → 2026-09-26

Core

Processing Individual Case Safety Reports (ICSRs), managing SAE/SUSARs, and supporting pharmacovigilance processes for pharmaceutical and biotechnology partners.

Role type

Associate pharmacovigilance specialist (ICSR management)

Builds

Safety reports and regulatory compliance documentation for clients

Domain

Life sciences / Pharmacovigilance

Deliverable

client delivery

Required skills

ICSR processing, SAE/SUSAR management, MedDRA and WHO coding, data reconciliation, quality complaint handling

Preferred skills

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

Technologies

PrimeVigilance platform, MS Office

Responsibilities

Processing ICSRs from all sources in compliance with regulations and client requirements; performing ICSR follow-up; managing SAE/SUSARs including unblinding and protocol review; handling product quality complaints; acting as LCPPV and PRLS for designated countries/languages

Seniority

Junior, entry-level 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.