Medical and PV Audit and Inspection Readiness Professional

at  Sanofi US

• Job title: Medical and PV Audit and Inspection Readiness Professional
• Location: Budapest, Hungary
• Flexible working: 60% home, 40% office
• Job type: Permanent, Full time

Responsibilities cover PV and Medical related activities across all Business Units, working directly with GBU Medical, Pharmacovigilance, Regulatory, and Clinical and across the local Sanofi commercial offices (all Sanofi legal entities), as well as with Country Quality teams and other Global Quality GxP operational units, as required.

The Audit and Inspection Readiness Prefessional is responsible to ensure:

• Support of the ongoing permanent inspection preparedness and readiness of Global Pharmacovigilance (Patient Safety Pharmacovigilance-PSPV) and country PV offices in anticipation of regulatory inspections and audits
• Support the preparation, conduct and follow-up of GxP regulatory inspections impacting PV until closure
• Active involvement in the organization of appropriate support for the preparation, conduct and follow-up of Global Quality audits impacting country GxP activities, global PV processes/tools or Business Partner audits, until closure
• The follow-up of audit/inspections PV-related Corrective and Preventive Actions (CAPAs) to ensure timely completion and coordination of CAPA effectiveness reviews in collaboration with CAPA owners, as needed to prevent recurrence
• The management of Business Partners and Global Service Providers PV Audits activity, in collaboration with external auditors and related PSPV functions