Senior Manager Inspection & Audit Readiness

Novartis Farmacéutica; London; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Manager for Inspection & Audit Readiness. This role is pivotal in managing global GVP/GCP inspections and audit readiness, ensuring compliance with regulatory requirements. You will coordinate expert input, maintain communication channels, and mentor teams for effective audit preparation. Join a passionate community dedicated to improving patient outcomes through innovative science and collaboration. If you are driven by a mission to make a difference, this opportunity is your chance to contribute to meaningful change in the healthcare landscape.

Qualifications

• Life science degree required with experience in Clinical Safety.
• Fluency in English and knowledge of global Pharmacovigilance regulations.

Responsibilities

• Coordinate global GVP/GCP inspections and audits.
• Provide guidance to SMEs and manage audit readiness.
• Conduct impact assessments for changes in regulations.

Skills

Fluency in English

Knowledge of global regulations for Pharmacovigilance

Experience in Clinical Safety Department

Global vision of Pharmacovigilance processes

Education

Life science Degree

Tools

SharePoint

Microsoft Teams

Job description

Senior Manager Inspection & Audit Readiness

Job ID REQ-10047751

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.