Analysis specialist

1 week ago


Montreal, Canada Novartis Full time
Montreal/Toronto, #LI-Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.Novartis, you will have the opportunity to be a part of an engaged and dedicated team that is committed to ensuring the safety of our patients. p>About the role:
The Patient Safety Specialist role is to support management of Patient Safety operational processes in Canada ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for vigilance of both marketed and investigational products (incl. drugs, and medical devices) from Novartis Group. This role will work directly with the Patient Safety and Pharmacovigilance team and reports to the Patient Safety Group Manager.Manage the collection, processing, documentation, reporting, reconciliation and follow-up of adverse event reports for all Novartis products.Handle reporting, submission, and distribution of safety reports to Local Health Authorities and clinical operations in collaboration with other departments.Develop and implement local procedures to ensure compliance with global Patient Safety procedures and national requirements.Collaborate with other departments to ensure adherence to Novartis vigilance requirements in projects involving safety data collection.Ensure adequate vigilance provisions in contracts.Support Pharmacovigilance activities such as local literature monitoring and training material preparation.Provide support for internal audits, Local Health Authority inspections, and implementation of CAPA plans.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.Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.Business Unit: Innovative Medicines

Site: Montreal

Company / Legal Entity: CA04 (FCRS = CA004) NOVARTIS PHARMA CANADA INC.

Job Type: Full time

Shift Work: No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.


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