Patient Safety Specialist

Major accountabilities:

Your responsibilities include, but are not limited to:

• 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.

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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
• Fluent in both written and spoken English and French

Desirable:

• Previous experience in the pharmaceutical industry or as a Patient Safety Specialist

Minimum Requirements: