Senior Manager Inspection & Audit Readiness

Senior Manager Inspection & Audit Readiness

Job ID REQ-

Apr 16, 2025

United Kingdom

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:

1. Responsible to provide coordination of central pharmacovigilance subject matter expert input and preparation for GVP or GCP inspections, EMA or national.
2. Establishment and maintenance of communication channels (SharePoint, Teams) for the inspection preparation.
3. Providing guidance to SME on expectations and content delivery.
4. Review of requests by inspectors and ensuring timely provision.
5. Maintenance of SME list.
6. Inspection observation impact assessment for vigilance partners.
7. Routine upcoming inspection notification to pharmacovigilance community in Novartis.
8. Responsible for the coordination and management of audits and audit readiness in the central sites, including response development.
9. Management of 1QEM for assigned audits.
10. Audit observation impact assessment for vigilance partners.
11. Collation of insights across audits to provide lessons learned and support self-assessment target identification.
12. Support mentoring for effective audit and inspection readiness in the global ESPs supporting pharmacovigilance activities.
13. 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.

Qualifications

• Life science Degree.
• Good knowledge / Fluency in English. Knowledge of other language 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.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Learn more .

Commitment to Diversity & Inclusion:

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

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GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.