Global PV Case Processing Lead

Arphia Partners; Paris; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Arphia Partners is seeking a Pharmacovigilance Case Processing Lead to join their Global Safety team in Paris. The role focuses on overseeing outsourced PV case processing from intake to regulatory submission for clinical and post-market cases, with an emphasis on quality control and risk mitigation.

You will work in an international, cross-functional environment, leveraging ARGUS expertise and deep PV regulation knowledge to ensure safety data integrity and timely submissions.

Qualifications

• 4+ years' Pharmacovigilance Case Processing experience (Global).
• Strong knowledge of global PV regulations and ICSR requirements.
• 1+ year experience working with ARGUS (recent).
• 2 years vendor oversight and quality management experience.
• Comfortable working in an international, cross-functional environment.

Responsabilités

• Vendor management of outsourced case processing activities from intake through regulatory submission for clinical and post-market cases.
• Quality review of vendor-managed IC tasks and data.
• Investigation of deviations, root cause analysis and CAPA management.
• Support clinical trials through Safety Management Plans and safety system configuration.
• Vendor management, reconciliation activities and operational oversight.
• Act as Subject Matter Expert during audits and inspections.

Connaissances

PV Case Processing

Vendor management

Regulatory knowledge

Global environment

Outils

ARGUS

Description du poste

Arphia Partners is seeking a Pharmacovigilance Case Processing Lead to join their Global Safety team in Paris. The role focuses on overseeing outsourced PV case processing from intake to regulatory submission for clinical and post-market cases, with an emphasis on quality control and risk mitigation.

You will work in an international, cross-functional environment, leveraging ARGUS expertise and deep PV regulation knowledge to ensure safety data integrity and timely submissions.