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Patient Safety Business Admin Learnership

The Programme 

To support Patient Safety operational processes at the Country Organization by ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis group marketed and investigational products (drugs and devices).

What You Will Do 

  • Support the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc.
  • Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality. 
  • Support reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities and/or clinical operations in cooperation with other Country Organization Departments. 
  • Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data. 
  • Interact and exchange relevant safety information with Patient Safety associates, other functional groups and third-party contractors, if applicable. 
  • Support the survey and monitoring of national Pharmacovigilance regulations. 
  • Support the development, update and implementation of local procedures to ensure compliance with Patient Safety global procedures and national requirements. 
  • Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources. 
  • Management and maintenance of all relevant Patient Safety databases. 
  • Support the preparation of KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to HA, development and implementation of corrective action(s) as needed. 
  • Support the development and update of training materials for Pharmacovigilance and the ensure training of Country
  • Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third-party contractors, if applicable. 
  • Support the close-out of actions from audits, corrective action plans, investigations and Health Authority inspections. 
  • Manage and maintain efficient Patient Safety filing and archive system. 
  • Timely and accurate capturing of data into the respective safety databases. 
  • Timely and accurate completion of monthly screening of the medical literature for new safety information. 
  • Completeness and correctness of the data received and sent out in respective tracking tools/system. 
  • Timely and quality preparation of documentation and presentation materials.
  • Positive feedback from PS Managers and other internal stakeholders.  

Required Skills and Abilities 

  • Health Sciences Degree 
  • Knowledge of pharmacological and medical terminology. 
  • Excellent communications, interpersonal and negotiation skills. 
  • Quality and focus oriented. 
  • Computer skills. 
  • Fluent in both written and spoken English. 
     
Closed a month ago
Closed a month ago
  • Job type:Graduate Jobs
  • Disciplines:

    Administration, Business and Commerce

  • Citizenships:

  • Locations:

    Gauteng (South Africa)

  • Closing Date:18th Dec 2021, 6:00 pm

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