Patient Safety Compliance Manager

23 hours ago


Ottawa, Ontario, Canada Novartis Farmacéutica Full time

We are seeking a skilled Patient Safety Compliance Manager to join our team at Novartis in Canada. This role is responsible for managing patient safety operational processes, ensuring compliance with global and local procedures, national and international regulations, standards, and guidelines.

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.
  • Evaluate adequacy of 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.
Requirements:
  • A 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.
  • Fluent in both written and spoken English and French.
  • Prior experience in the pharmaceutical industry or as a Patient Safety Specialist.

This is an exciting opportunity to work with a leading pharmaceutical company and contribute to the safety of patients. The estimated annual salary for this position is approximately $95,000 - $110,000 CAD, depending on experience and qualifications.



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