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Patient Safety Specialist

2+ years
Not Disclosed
10 Dec. 14, 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

Here’s a refined version of the Patient Safety Specialist role at Novartis:


Position: Patient Safety Specialist

Location: Montreal/Toronto, Canada | #LI-Hybrid
Company: Novartis Pharma Canada Inc.
Division: International | Innovative Medicines


About Novartis

Novartis is dedicated to improving patient lives by pioneering innovative medicines and creating an inclusive, diverse environment. Join our engaged team of professionals who are working collaboratively to make breakthroughs that benefit patients worldwide.


About the Role

The Patient Safety Specialist will play a critical role in ensuring the safety of Novartis products, including both marketed and investigational drugs and medical devices. You will collaborate closely with the Patient Safety and Pharmacovigilance teams to manage patient safety processes in Canada, adhering to global and local regulations and guidelines.


Key Responsibilities

  • Adverse Event Management: Collect, process, document, report, reconcile, and follow up on adverse event reports for all Novartis products.
  • Safety Reporting & Submission: Handle the submission and distribution of safety reports to Local Health Authorities and clinical operations, working closely with other departments.
  • Compliance Procedures: Develop and implement local procedures to ensure compliance with global Patient Safety procedures and national regulations.
  • Cross-Department Collaboration: Work with other teams to ensure adherence to vigilance requirements in projects related to safety data collection.
  • Safety Provisions in Contracts: Ensure adequate vigilance provisions are included in contracts.
  • Pharmacovigilance Activities: Support local pharmacovigilance tasks, including literature monitoring and the preparation of training materials.
  • Audit and Compliance: Assist in internal audits, Local Health Authority inspections, and the implementation of CAPA (Corrective and Preventive Actions) plans.
  • Reporting: Prepare compliance reports and identify root causes for delays in reporting, implementing corrective actions as necessary.

What You’ll Bring to the Role

  • Essential Qualifications:

    • Healthcare Professional (e.g., Medical Doctor, Nurse, Pharmacist) or a life science degree with relevant training or experience.
    • Knowledge of national and international pharmacovigilance regulations.
    • Proficient in pharmacological and medical terminology.
    • Strong communication, interpersonal, and organizational skills.
    • Quality and results-oriented mindset with strong computer skills.
    • Fluent in both written and spoken English and French.
  • Desirable Qualifications:

    • Previous experience in the pharmaceutical industry, especially in pharmacovigilance or as a Patient Safety Specialist.

Why Novartis?

At Novartis, we foster a dynamic, collaborative environment where passionate individuals work together to tackle challenging health issues. Join us in our mission to change patients’ lives for the better.


Benefits and Rewards

Explore the comprehensive benefits designed to help you thrive personally and professionally. Visit Novartis Careers to learn more.


Equal Opportunity Employer

Novartis is an Equal Opportunity employer, committed to providing reasonable accommodations for individuals with disabilities during the recruitment process and in performing job functions. Please contact diversityandincl.canada@novartis.com for assistance.


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