Patient Safety Specialist

Job Description Summary

Location: Montreal or Toronto, #LI-Hybrid

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Temporary 12 month contract

We are currently looking for a skilled and dedicated Patient Safety Specialist to join our team. By joining 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. Additionally, you will collaborate with various functions within the company to meet Novartis objectives and fulfill the requirements set by Health Authorities.

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.

Job Description

Job Description

Key responsibilities:

• 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.
• Prepare and submit compliance reports, identifying root causes for late reporting and implementing corrective actions.
• Provide support for internal audits, Local Health Authority inspections, and implementation of CAPA plans.

What you’ll bring to the role:

Essential:

• Healthcare Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience.
• Knowledge of national and international regulations for pharmacovigilance
• Knowledge of pharmacological and medical terminology
• Good communication and interpersonal skills
• Quality and results oriented
• Computer skills

Desirable:

• Previous experience in the pharmaceutical industry or as a Patient Safety Specialist
• Fluent in both written and spoken English and French is an important asset

Skills Desired

Databases, Employee Training, Filing Documents, Pharmacovigilance, Reporting, Safety Science

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