About the Role

　　Role Purpose

　　To support management of Patient Safety operational processes at Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for vigilance of both marketed and investigational products (incl. drugs, food supplements and medical devices) from Novartis Group.

　　These learnership opportunities means that the succesfull candidates will complete the Business Administration qualification (NQF 4. ID: 61595) and do workplace experience with the workplace company whilst at the same time complete the portfolio of evidence as prescribed by the learnership qualification.

　　Major Accountabilities

　　• 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 Orient-ed 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.

　　• Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness. When case processing activities are ex-eternalized, liaise with the respective External Service Providers to ensure Novartis Procedures' compliance.

　　• Support reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments.

　　• Interact and collaborate with other departments (such as Medical Affairs, Marketing, Patient Engagement, etc.) to ensure that any projects/ initiatives that potentially involve safety data collection (POPs, DEAs, SM/SML, etc.) follow the Novartis vigilance requirements.

　　• 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 ensure training of Country Organization associates on relevant Patient Safety procedures for AE re-porting, 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.

　　• Support and maintain efficient Patient Safety filing and archive system.

　　Key Performance Indicators

　　• 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

　　Diversity & Inclusion / EEO

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

　　Role Requirements

　　Education: Health Care Sciences _life science degree or equivalent training and experience.

　　Languages:

　　• Fluent in both written and spoken English

　　• Fluent in both written and spoken local language

　　Experience/Professional Requirement:

　　• Knowledge of national and international regulations for pharmacovigilance

　　• Knowledge of pharmacological and medical terminology

　　• Good communication and interpersonal skills

　　• Quality and results oriented

　　• Computer skills

　　NB: In order to be considered for the learnership:

　　1) No prior work experience is mandatory

　　2) Your application must be supported by a motivational letter and your academic transcripts

　　The Company's approved Employment Equity Plan and Targets will be considered as part of the recruitment process. As an Equal Opportunities employer, we actively encourage and welcome people with various disabilities to apply. Novartis recognizes, appreciates and values diversity & inclusion.

　　Division

　　Development

　　Business Unit

　　Patient Safety & Pharmacovigilance

　　Location

　　South Africa

　　Site

　　Gauteng

　　Company / Legal Entity

　　Novartis SA (Pty) Ltd.

　　Functional Area

　　Interns/Students on Novartis Payroll

　　Job Type

　　Full Time

　　Employment Type

　　Internship

　　Shift Work

　　No