Portfolio Coordinator X3: Health Products Authorisation at South African Health Products Regulatory Authority

REQUIREMENTS:

• Matric certificate and appropriate Science Degree with Honours at NQF Level 8, as recognised by the South African Qualifications Authority (SAQA), OR a 4-year degree in Health Science at NQF Level 8, as recognised by SAQA, and registration with a statutory council if applicable. Certificate in Project Management will be an added advantage. 

EXPERIENCE:

• A minimum of five (5) years of relevant work experience with 3 years’ experience in a regulatory environment. Management experience as well as experience in the Medicines Regulatory environment, and Risk and Software management will be an added advantage. Valid driver’s license. 

DUTIES:  

Operational Management: 

• Manage the application receipt and preliminary review to verify that applications are compliant to SAHPRA’s requirements and determine whether the applications may advance to the review phase: Verify and ensure that submitted applications are received and recorded on the relevant trackers/databases and medicines register. Verify and ensure that technical screening of applications and responses is performed in accordance with the validation, screening templates or checklists, timeously and according to the units work plan and submission schedules. Quality check and approve admin and technical screening in accordance with the validation template or checklist and upload to the file plan. Ensure that status information is captured on the tracker/ database by the relevant screeners.
• Manage/the allocation, recording and monitoring of applications: Compile and maintain a list of the expertise of evaluators. Ensure that the tracker is updated routinely by the relevant evaluator coordinator for traceability and transparency of applications. Ensure that the applications are allocated based on the level of expertise and availability of evaluators. Monitor applications in progress to ensure timeous interventions and develop contingency plans for potential problems where applicable.Conduct quality control checks on the evaluation reports and queries/approval letters and ensure they are uploaded on the file plan. Conduct quality checks on applicable documents and ensure the database records are updated accordingly.   

 Financial Management: 

• Oversee the claims and revenue process: Verify claims received are recorded and submitted to finance timeously. Check for correct claim codes on claim forms submitted by evaluators to ensure that the evaluators are paid correctly and that the units expenditure is managed appropriately. Verify collation of revenue information for received applications. Fosters an environment where cost-benefit outcomes are continuously improved by checking that POE’s are compiled correctly. 
• Governance, Risk and Compliance: Check for compliance and ensure reports/letters are completed on the latest QMS controlled version of the evaluation letters/ templates. Conduct self-inspections of work practices, record deviations to ensure adherence to standard operating procedures and SAHPRA guidelines. Develop, maintain and distribute SOPs and templates. Develop work plans and/or programmes to implement provided strategic direction.Support unit with QMS internal and external audits including ISO 9001:2015 certification by responding swiftly to any non-conformances or audit findings that are raised. Develop an action plan and tracker in collaboration with the HPA Team. 
•  People Management: Drive a high-performance culture within the HPA team. Drive a culture of personal and professional development. Living the SAHPRA Values. Drive collaborative leadership. Manage workstream staff members’ compliance with organisational policies and procedures by performing regular performance assessments and implementation of individualised interventions where applicable and escalating further non-compliance.