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Patient Safety Specialist

2+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Patient Safety Specialist
Location: Montreal/Toronto, Canada (#LI-Hybrid)

Novartis is looking for a skilled Patient Safety Specialist to join its dedicated team. This role focuses on ensuring the safety of patients by managing pharmacovigilance activities in compliance with both local and global standards.

About the Role
The Patient Safety Specialist supports the management of patient safety operational processes in Canada, ensuring adherence to regulations and guidelines for the vigilance of marketed and investigational products. Reporting to the Patient Safety Group Manager, this role collaborates with various internal functions to achieve Novartis' safety objectives and comply with Health Authority requirements.

Key Responsibilities

  • Adverse Event Reporting:
    • Collect, process, document, reconcile, report, and follow up on adverse events for all Novartis products.
  • Regulatory Submissions:
    • Prepare and distribute safety reports to Local Health Authorities and clinical operations in collaboration with internal departments.
  • Compliance and Procedures:
    • Develop and implement local procedures ensuring compliance with Novartis’ global Patient Safety standards and local regulations.
    • Ensure vigilance provisions are adequately addressed in contracts.
  • Collaboration and Training:
    • Work with other departments on safety data collection and pharmacovigilance training material preparation.
    • Support pharmacovigilance activities such as local literature monitoring.
  • Audit and Inspection Readiness:
    • Assist with internal audits, Health Authority inspections, and implementation of Corrective and Preventive Action (CAPA) plans.
    • Prepare compliance reports, analyze late reporting causes, and implement corrective actions.

What You’ll Bring to the Role

  • Essential Requirements:
    • Degree in healthcare (e.g., Medical Doctor, Nurse, Pharmacist), life sciences, or equivalent experience.
    • Knowledge of national and international pharmacovigilance regulations.
    • Familiarity with pharmacological and medical terminology.
    • Strong communication, interpersonal, and computer skills.
    • Fluent in English and French (written and spoken).
  • Desirable:
    • Previous experience in the pharmaceutical industry or as a Patient Safety Specialist.

Why Novartis?
At Novartis, collaboration and innovation drive breakthroughs that improve patients' lives. Be part of an inspiring team dedicated to building a brighter future through cutting-edge science.

Benefits and Rewards
Explore the ways Novartis supports your personal and professional growth in the Novartis Life Handbook.

Diversity and Inclusion
Novartis is committed to fostering an inclusive environment and building diverse teams that reflect the communities we serve.

Stay Connected
Not the right role for you? Join our Novartis Network to stay informed about future opportunities.

Division: Development
Business Unit: Innovative Medicines
Job Type: Full-Time
Employment Type: Regular