Patient Safety Specialist
Patient Safety Specialist
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Job Description
Job Description Summary
Location: Montreal/Toronto #LIHybridNovartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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. 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
Key responsibilities:
- Manage the collection processing documentation reporting reconciliation and followup 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.
- 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 youll 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
Fluent in both written and spoken English and French
Desirable:
Previous experience in the pharmaceutical industry or as a Patient Safety Specialist
Skills Desired
Databasing Employee Training Filing Documents Management Reporting Pharmacovigilance Safety ScienceRequired Experience:
Unclear Seniority
Employment Type
Full-Time
