Pharmacovigilance QC Reviewer – Team Lead IV

Location: Plainsboro, NJ (Hybrid – at least 3 days/week onsite)
Duration: 1-Year Contract
Employment Type: Contract

Position Summary

Our well known client is seeking a seasoned Pharmacovigilance QC Reviewer – Team Lead IV to lead and manage PV case management operations as part of its growing quality oversight team. This is a hybrid position requiring leadership in pharmacovigilance processes, from case intake through the submission of Individual Case Safety Reports (ICSRs), as well as team leadership and quality control expertise.

Key Responsibilities

• Lead and manage PV case processing activities across a team of professionals
• Oversee end-to-end pharmacovigilance case handling, including intake, documentation, quality control, and submission of ICSRs
• Perform extensive quality control reviews of safety cases to ensure compliance with FDA 21 CFR Post-Marketing regulations and internal SOPs
• Provide guidance and training to team members; act as escalation point for technical or process-related issues
• Monitor team performance and ensure high-quality standards and turnaround times are met
• Utilize safety databases such as Argus and internal systems for processing and quality oversight
• Identify process gaps or nonconformities and escalate findings appropriately

Qualifications

• Bachelor’s degree minimum required; must hold a healthcare provider degree (e.g., pharmacist, nurse); advanced degree preferred
• 8+ years of pharmaceutical industry experience, including:
• 5+ years in pharmacovigilance case management and team leadership
• 3+ years in broader pharmaceutical/PV roles
• Proven team management or team lead experience within PV operations
• Strong working knowledge of safety database systems (e.g., Argus)
• Proficient in MS Office (Outlook, Excel, Word)
• Strong analytical, written, and verbal communication skills