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.
- Job type:Graduate Jobs
Administration, Business and Commerce
Gauteng (South Africa)
- Closing Date:18th Dec 2021, 6:00 pm