•be the responsible person for pharmacovigilance for both pre- and post- marketing surveillance.
•be part of the team and be responsible for establishing and maintaining the local PV system in accordance with legal requirements, corporate standards and best practice within the pharmaceutical industry.
•Contribute to all local safety aspects of clinical development programs, observational studies and patient data collection systems sponsored by the company; perform active PV and product surveillance at local level to ensure up to date benefit-risk profiles of all products marketed by the affiliates.
•Process all product safety complaints and/or adverse events, including tracking, record keeping and resolving the complaint with a formal response to the complainant.
•Screening and review of published scientific literature to screen for safety information that maybe reported therein.
•will be serving as a contact person for South African Medical Control Council for all matters relating to pharmacovigilance
•Act as local contact person for medical enquires and to provide timely response in accordance to the local approved product information and keep abreast of all relevant changes in local regulatory standards
the preparation of the following for periodically submission to the authority:
•adverse reaction reports
•summary report of ADRs
•periodic safety update reports when necessary
Licensing & Compliance Services
Good Manufacturing Practice (GMP) is an international standard that governs all the activities related to product quality.
The South African Regulatory Authority describes GMP as “That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the medicine registration or product specification. GMP is concerned with both production and quality control”.
Depending on the business and its intended activities, all pharmaceutical companies in South Africa require licensing with both the Medicines Control Council and the Department of Health. We assist with the following: