Pharmacovigilance QC Reviewer II

Location: Plainsboro, NJ (Hybrid – minimum 3 days/week onsite)
Duration: 1 Year Contract

Overview

Our well known client is expanding its Pharmacovigilance (PV) Oversight Team and seeking Pharmacovigilance QC Reviewer II professionals. This role is ideal for individuals with a healthcare provider degree (HCP) and extensive PV case processing and quality control experience. As part of a growing safety organization, you’ll play a vital role in ensuring compliance and accuracy of post-marketing Individual Case Safety Reports (ICSRs).

Key Responsibilities

• Perform end-to-end pharmacovigilance case handling, from intake through ICSR submission
• Conduct extensive quality control (QC) reviews of ICSRs to ensure compliance with FDA 21 CFR Post-Marketing regulations
• Identify and escalate nonconformance issues through appropriate channels
• Work within multiple safety databases including Argus and internal systems
• Collaborate closely with cross-functional teams to support safety reporting initiatives

Required Qualifications

• Bachelor’s degree minimum; must hold a healthcare provider degree (e.g., pharmacist, nurse)
• 3+ years of hands-on experience in pharmacovigilance case processing
• Strong experience in safety database systems (e.g., Argus) and quality control of safety reports
• Excellent verbal and written communication skills
• Proficiency in Microsoft Outlook, Excel, and Word