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Patient Safety Senior Specialist

2+ years
Not Disclosed
10 July 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Summary Support the management of Patient Safety operational processes at the Country Organization, ensuring adherence to Novartis global and local procedures, as well as national and international regulations and standards for vigilance of marketed and investigational products, including drugs, food supplements, and medical devices from Novartis Group. Mentor less experienced Patient Safety associates and support local projects/initiatives in collaboration with the Cluster Patient Safety Head and/or Patient Safety Group Manager.

About the Role Major Accountabilities:

  • Develop, update, and implement local procedures to comply with Patient Safety global procedures and national requirements.
  • Collaborate with departments such as Medical Affairs, Marketing, and Patient Engagement to ensure safety data collection projects align with Novartis vigilance requirements.
  • Manage and distribute vigilance clauses to departments like Legal and Procurement for inclusion in local agreements when necessary.
  • Advise owners of local contracts on vigilance provisions required per Novartis procedures and applicable regulations.
  • Develop and update training materials for vigilance and ensure training of Country Organization associates, including field force and third-party contractors, on AE reporting.
  • Support internal audits, LHA inspections, and implementation of CAPA plans.
  • Onboard new PS associates and mentor less experienced associates in collaboration with the Cluster Patient Safety Head or Patient Safety Group Manager.

Minimum Requirements:

  • Scientific degree (preferably Medical Doctor, Nurse, Pharmacist) or 2+ years of experience in a similar position.
  • Knowledge of national and international pharmacovigilance regulations.
  • Understanding of pharmacological and medical terminology.
  • Strong communication and interpersonal skills.
  • Quality and results-oriented approach.
  • Project management skills.
  • Proficient computer skills.

Why Novartis? Our mission is to reimagine medicine to improve and extend people’s lives. We aim to become the most valued and trusted medicines company globally. This vision is driven by our associates, who work passionately to achieve our goals. Learn more here.

Commitment to Diversity and Inclusion: Novartis is dedicated to creating an outstanding, inclusive work environment and building diverse teams representative of the patients and communities we serve.

Join our Novartis Network: If this role doesn’t match your experience or career goals but you're interested in future opportunities, join the Novartis Network here to stay connected.

Details:

  • Division: Development
  • Business Unit: Innovative Medicines
  • Location: Hungary
  • Site: Budapest
  • Company/Legal Entity: HU02 (FCRS = HU002) Novartis Hungary
  • Functional Area: Research & Development
  • Job Type: Full-time
  • Employment Type: Temporary (Fixed Term)
  • Shift Work: No