摘要
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 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? : http://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: http://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? http://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: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
