Senior Manager Inspection & Audit Readiness

ZipRecruiter; Dalkeith; On-site; GBP 125,000 - 150,000; Full time

Job description

Job Description

This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the + business community. Please do not contact the recruiter directly.

Summary: Responsible for management and coordination of global GVP/GCP inspection & audit participation, conduct of global PS&PV self-assessments and contribute to review of draft, new and changed pharmacovigilance/device vigilance regulatory requirements.

About the Role

Major accountabilities:

• Responsible to provide coordination of central pharmacovigilance subject matter expert input and preparation for GVP or GCP inspections, EMA or national.
• Establishment and maintenance of communication channels (SharePoint, Teams) etc for the inspection preparation.
• Providing guidance to SME on expectations and content delivery.
• Review of requests by inspectors and ensuring timely provision.
• Maintenance of SME list.
• Inspection observation impact assessment for vigilance partners.
• Routine upcoming inspection notification to pharmacovigilance community in Novartis.
• Responsible for the coordination and management of audits and audit readiness in the central sites, including response development.
• Management of 1QEM for assigned audits.
• Audit observation impact assessment for vigilance partners.
• Collation of insights across audits to provide lessons learned and support self-assessment target identification.
• Support mentoring for effective audit and inspection readiness in the global ESPs supporting pharmacovigilance activities.
• Support global PS&PV self-assessment facilitation and management. Deputise for Global Head, I&AR in the review of draft, new or revised pharmacovigilance/device vigilance regulatory initiatives, requirements and guidelines. When required, conduct an impact assessment for changes in requirements impacting audits and inspections.

Minimum Requirements:

• Life science Degree.
• Good knowledge /Fluency in English. Knowledge of other languages is desirable.
• Experience mainly in a Clinical Safety Department & closely related areas e.g., Clinical Development.
• Must have knowledge of global regulations for Pharmacovigilance/Device vigilance.
• Global vision of Pharmacovigilance/device vigilance process inter-relationships.

Commitment to Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards