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 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

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

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