Experience

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  Mathematics specialist

  May 2018 - Jan 2021

  Co executive director

  Design and implement business strategies, plans, and procedures -Set comprehensive goals for performance and growth -Establish policies that promote company culture and vision -Oversee daily operations of the company and the work of executives. -Lead employees to encourage maximum performance and dedication. -Evaluate performance by analyzing and interpreting data and metrics. -Write and submit reports to the CEO in all matters of importance -Assist CEO in fundraising ventures -Participate in expansion activities (investments, acquisitions, corporate alliances, etc.) -Manage relationships with partners/vendors. Show less

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  Moses kotane institute

  Jun 2020 - Dec 2020

  Data collector

  Duties: sorting data, creating statistical models, administering surveys, delivering presentations and reports, cleaning data, making corrections, and doing basic statistical work.

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  University of kwazulu-natal

  Feb 2021 - Sept 2022

  Teaching assistant

  Determine students' needs in learning and possible barriers.Promote engagement or discussion among students, leading to proper diagnosis and management of diseases.Ensure learning methods selected are appropriate for the learning outcomes.

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  Abbott

  Feb 2022 - Aug 2023

  Medical and regulatory affairs trainee

  Workplace program in collaboration with Mediscor PBMAligns closely and works collaboratively with Medical/Marketing teams to develop and execute Medical Plans.Develops deep understanding of the local patient-population demography, dynamics and healthcare needs and uses this knowledge to inform strategy development.Adds therapeutic area expertise to the medical team, and transfers knowledge within the organisation and externally.Supports execution of the commercial and medical strategies.Lead regulatory input into assigned projects that enables the landing of compliant, competitive products in the market.Provide a regulatory assessment and advise on risks for the countries in which the product is to be marketed.Provides regulatory updates on regulations affecting the cluster/category on the specific area/category , gives/organizes trainings.Anticipates regulatory challenges for the future which could drive the external influencing agenda for the cluster as input for the advocacy agenda, innovation plan. Show less

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  Mediscor pbm

  Nov 2022 - Aug 2023

  Medical affairs trainee

  I am under Medical Affairs department (My workplace program is in collaboration with Abbott Laboratories SA PTY(LTD) Responsibilities:Medical Schemes Acts Experience in interpreting and applying schemes rules correctly National health reference price list (NHRPL), SAMA tarrifts, ICD10, and CPT (CCSA) coding Drafting funding policies and reviewing dossier.Recording and documenting clinical meetings. Project management. Medicine reimbursement policy development.Formulary development and maintenance.Critical evaluation of medicine and medical products by applying the principle of evidence-based medicine. Good knowledge of pharmacovigilance and local regulatory process and it impact on the product portfolio.Conducting literature reviews.Developing scientific material Creating medical responses. Collaborating and support medical education initiatives.Working with medical schemes (funders), market access managers (From Pharmaceutical and Technology Manufacturers) and regulators from Council of medical schemes (CMS) or SAHPRA.Drug information searches.Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.Serve on Pharmacy and Therapeutics committee responsible for review of medicineformularies. Show less

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  Pharma dynamics (pty) ltd

  Aug 2023 - now

  Regulatory affairs scientist

  Conduct due diligence on received change controls, variation packages, and dossiers pertinent to, but not restricted to, LCM of the assigned product portfolio. Identify and maintain updates on existing products based on SAHPRA guidelines and allocated priorities. involved in variations, certificate variations and new medicines registration. Review of quality aspects of the dossier.Evaluation of Type I and II variations pertaining to quality accepts of the dossier. Develop and update SOPs and GuidelinesRisk Management and Audit Forms part of technical working groups and special projects and also providing support advisory committees. Interact on a regular basis with PD departments, overseas affiliates, third parties and contractors on dossier related activities. Liaise with SAHPRA on behalf of Pharma Dynamics on new and existing queries, as and when required. Compile and submit all responses to SAHPRA recommendations, Safety Updates and variations, within agreed and specified time limits. Maintain the department’s online apps (CCP database, docuBridge, AW app etc) as per official SOPs and/or working instructions. Assistance with the artwork process to finalise printed packaging components in submitted countries in line with Act 101 and the Marketing Code.eCTD/CTD compilation | Lorenz | docuBridge & eValidation | Review, Compilation and Validation &Publishing of Dossier | Pre & Post Approval |Adobe Acrobat | MS suite Show less