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
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