This is a temporary contractor opportunity at Novartis

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

This role is offered through Magnit Global, who, if selected, will be your employer. If your services are retained, you will be assigned to provide services to Novartis as the end client. This is not an offer of employment with Novartis. If you are selected for this Temporary/External opportunity, you will not be an employee of Novartis and will not be eligible for any Novartis employee benefits or incentives.

Ready to work with/through Magnit at Novartis? Please read on…

Major accountabilities:

• Support management of operational processes in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products.
• Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
• Liaise with the respective External Service Providers to ensure Novartis Procedures’ compliance with transcribing and entering data of all Adverse Events from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
• Record and track receipts, submissions and distributions of documents like SAEs and SRs, in cooperation with other departments.
• Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
• Work with other local/global PV associates to ensure accurate evaluation of safety data.
• Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third party contractor, if applicable.
• Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization.
• Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.
• Management and maintenance all relevant assigned PVO databases, if applicable.
• Develop and update training materials for pharmacovigilance
• Ensure support for and close-out of audits, corrective action plan activities and Health Authority inspections.
• Provide timely, relevant information to trial coordinators, CRAs and other Novartis staff.
• Distribution of marketing samples (where applicable).