직무 설명

Role overview

An innovative biotech company is looking for a Pharmacovigilance Associate to support routine drug safety operations on a contract basis. This position is suited to someone with early-stage experience in pharmacovigilance who wants to deepen their knowledge of case handling, safety systems, and regulatory compliance in a dynamic environment.

Assignment details

Contract duration: 6 months, with the possibility of an extension or conversion to a full-time role.
Work schedule: 40 hours per week.
Work mode: Remote.

Key responsibilities

Handle adverse event case processing and participate in quality review checks.
Support safety data management activities and reconciliation tasks.
Work with internal teams and external collaborators to keep safety operations running smoothly.
Help with inspection readiness efforts and ongoing process enhancements.

Required experience and knowledge

1 to 3 years of experience in pharmacovigilance or drug safety.
Strong preference for candidates with a PharmD.
Practical exposure to ICSR case processing and quality control review.
Experience using safety databases and managing the full case lifecycle, from intake through submission or distribution.
Ability to support case follow-up and maintain data quality throughout the workflow.
Working understanding of global pharmacovigilance regulations and guidelines, including ICH E2A, E2B(R3), and E2D, as well as FDA and EMA reporting concepts.
Familiarity with pharmacovigilance SOPs.
Knowledge of medical coding practices and safety data quality standards.

Additional information

This opportunity is intended for a candidate who can contribute effectively in a fast-moving biotech setting and grow within drug safety operations.

Application note

The hiring team invites interested candidates to get in touch directly for more details.

Pharmacovigilance Associate (Contract)