Sandoz Hiring Medical Safety Specialist

Sandoz Hiring Medical Safety Specialist

18 March, 2023

Sandoz Hiring Medical Safety Specialist

Your responsibilities include, but are not limited to:

  • Provide support according to the needs for delivery activities, co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.
  • Assist the GPSL/MSL/MSE in monitoring the safety profile of products including with activities such as literature review, medical assessment, and related activities for single cases, including collecting additional follow-up information as necessary.
  • Support Literature review for PSUR inclusion and assessment of literature for signals. Together with the Safety Leads, co-author the PSUR sections as required.
  • Reviewing HA assessment reports and engaging and supporting the appropriate safety leads to address the questions by the HA
  • Assist in evaluating and writing other safety deliverables including but not limited to Clinical Overview, Risk Management Plan (RMP), Development Safety Profiling Plan (d-SPP), and Development Safety Update Report (DSUR).
  • Support the safety lead with medical assessment of product quality issues (e.g. – Filling out relevant sections of the MRA)
  • Support in preparation of responses to internal safety requests and contribute to responses to external safety queries. Writing of meeting minutes. Document archival and formatting
  • Updating the Medical Safety SharePoint, uploading of documents, tracking and planning list updates

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

  • Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Life sciences graduate
  • Fluent in spoken and written English. Understanding in another major language (e.g. French, German, and Spanish) desirable.
  • 3 years in patient safety. Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries
  • Good understanding of clinical trial methodology, ICH GCP, GVP guidelines and medical terminology
  • Attention to detail and quality focused; Good communication skills, and the ability to operate effectively in an international environment
  • Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process
  • Good presentation skills; Good computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases/applications

Apply Online

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