Senior Manager Inspection & Audit Readiness
Company
Location
London, England, United Kingdom
Posted At
5/8/2025
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Description
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:
Commitment To Diversity & Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join Our Novartis Network
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
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.
- Life science Degree
- Good knowledge /Fluency in English . Knowledge of other language desirable.
- Experience mainly in a Clinical Safety Department & closely related areas eg Clinical Development.
- Must have knowledge of global regulations for Pharmacovigilance/ Device vigilance
- Global vision of Pharmacovigilance/device vigilance process inter-relationships
Commitment To Diversity & Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join Our Novartis Network
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
Advertise with us by contacting: [email protected]
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