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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
SENIOR MANAGER: HEALTH PRODUCTS AUTHORISATION (HPA)
Salary: Level 14 (R1 333 449.00 – R1 415 289.00) TOTAL COST TO COMPANY
Ref No.: SAHPRA 027/2023
CENTRE: Pretoria
REQUIREMENTS: 1. Appropriate 3-year degree in Chemistry or Bachelor of Pharmacy Degree (registered with SAPC). *Postgraduate or Management Degree preferable. *Sound and in-depth knowledge of the Medicines and Related Substances Act 101, 1965 as amended and the regulations pertaining to the Act. *Sound knowledge of regulatory scientific and technical requirement (to assess the quality, safety, and efficacy aspect). *Sound and in-depth knowledge of the administrative processes for registration of medicines in the Republic of South Africa. *A valid driver’s licence.
EXPERIENCE: * Minimum 8 years appropriate experience in relevant profession after registration with HPCSA (where applicable).
TECHNICAL PROFICIENCIES:
• Regulatory Sciences: *Knowledge or work experience with health product registration applications, or possibly with assessing the compiled applications. *Thorough understanding of the Regulatory environment that SAHPRA operates within (applicable legislation knowledge and understanding).
• Project Management: *Project Management experience within a Prince2, Agile, Scrum etc. framework. *Customer services experience/exposure.
CORE COMPETENCIES: *Effective Communication Skills. *Solid Leadership and Management Skills. *Ability to communicate complex technical concepts to non-technical stakeholders. *Solid Project Management experience. *Critical/Conceptual & Strategic thinking skills – allowing ICT strategies and business goals to be efficiently aligned. *High level of self-awareness. *Problem solving skills *Report writing skills. *Resilience. *Business Acumen. *Adaptability. *Solid Stakeholder management skills. *Solid Vendor management skills. *Knowledge and understanding of the Public Finance Management Act, including proven experience in its application. *Knowledge, understanding, and practical experience working in an ISO 9001 quality management systems environment.
RESPONSIBILITIES & DUTIES:
The role involves planning, project co-ordination, implementing, and maintaining all programme operational initiatives that will ensure effective management of applications, related records, reporting requirements, management of stakeholder and representing the HPA programme at senior management level and on external forums.
• Strategic Planning: *Develops an annual strategy, plan and budget (APP) for the division aligned with organisational needs and ensuring the most effective utilisation of resources.
• Team Management: *Leading and managing a team of IT professionals, including assigning tasks, providing guidance, concluding annual performance contracts, evaluating performance at mid-year and year-end, managing poor performance or disciplinary infractions, Leave Planning and management and fostering a collaborative work environment.
• Budgeting, Procurement and Resource Allocation: *Managing the HPA budget which includes submitting annual budget plan to Finance at communicated deadline and ensure that any/all planned CAPEX items and current and planned OPEX items are correctly accounted for, track and manage monthly expenses and revenue plan against budget to ensure overspend is avoided, revenue is collected in full in a timely manner, that team resources effectively allocated to complete work load within the operational area to manage work prioritise of the programme.
• Project Management: *Leading and managing identified and agreed HPA projects from start to finish, ensuring that projects are delivered on time, within budget, and meet stakeholders' requirements and related project governance structures and documentation is in place, including Project scope, project plans, Resource, Issues, Risks, Decisions and Quality registers and Project SteerCo with scheduled and minuted meetings. *Implement Project Management principles within the work streams to enable the Unit Manager(s), Portfolio Co-ordinators and Evaluator Co-ordinators to plan the work activities, co-ordinate support activities with the technical units, manage the resources in the workstream to ensure that ultimately, we progress rapidly with registration of new technologies and health products within identified target timelines.
• Stakeholder Management: *Cultivate and support Customer centric mindset within the HPA workstreams – ensuring that we follow our documented work practices to provide good and consistent service to all our stakeholders (internal and external)
Manage pro-active communication to various stakeholder groups to provide updates and pertinent information as it relates to HPA services and performance reporting.
• Training and Development: *Identifying training needs for HPA staff, organizing training programs, and promoting professional development to enhance the skills and knowledge of the HPA team. Ensure that all HPA Team members have been trained on all organisational policies and applicable standard operating procedures and guidelines and related proof of training/competence has been recorded and is on personnel file with HR.
• Continuous Improvement: *Staying updated on emerging operations and administrative trends within regulators, best practices, and regulatory requirements.
*Continuously evaluating and improving HPA work stream processes, systems, and policies to drive efficiency and effectiveness.
*Responding swiftly to any non-conformances or audit findings that are raised, ensure that that an Action plan and tracker is developed in collaboration with the whole HPA Team – detailing issue raised, responsible person, target due date, action to be taken and status of the open item. Ensuring that findings are closed with the 30-day timeline from when issue was raised to issue closed.
• Provide ad hoc support as discussed and instructed by the Chief Operations Officer: *Provide ad hoc support for additional tasks, as discussed, and instructed by the Chief Operating officer for interventions within the HPA functional area.
• Manage reporting requirements within communicated and agreed timelines: *Ensure that weekly HPA department meetings are set up with COO. Prepare and agenda for the weekly department meetings and provide the rolling tracker with updates the morning before the meeting to allow COO adequate time to prepare for the discussions. *Ensure committed activities are completed and reported on in sufficient detail. (Agenda broken up into 15 min to spend on new issues raised by manager, 30 min allocated rolling tracker update and last 15 min for COO to raise/update manager on new issues/matters). *Provide real-time updates to the COO on any matters that impact Key responsibility. *It is imperative that the HPA Manager keeps the COO abreast of events, deviations, performance related matters, incidents etc. that impact performance and service or might require escalated intervention. *Ensure that the quarterly HPA Performance Information Report and AOP reporting is submitted to the Business Planning Manner in accordance with communicated deadline and on the approved template. *Ensure that the quarterly TORS committee contribution is submitted to the Office Manager of the CRO in a timely manner so that the presentation can be submitted to TORS on time. *Develop and maintain any additional reports that may be required as a consequence of project related activities or ad hoc reports as requested from time to time. *Develop and maintain any operational report that is required to monitor the performance of the individual workstream teams.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 27 JULY 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
SENIOR MANAGER: HEALTH PRODUCTS AUTHORISATION (HPA)
Salary: Level 14 (R1 333 449.00 – R1 415 289.00) TOTAL COST TO COMPANY
Ref No.: SAHPRA 027/2023
CENTRE: Pretoria
REQUIREMENTS: 1. Appropriate 3-year degree in Chemistry or Bachelor of Pharmacy Degree (registered with SAPC). *Postgraduate or Management Degree preferable. *Sound and in-depth knowledge of the Medicines and Related Substances Act 101, 1965 as amended and the regulations pertaining to the Act. *Sound knowledge of regulatory scientific and technical requirement (to assess the quality, safety, and efficacy aspect). *Sound and in-depth knowledge of the administrative processes for registration of medicines in the Republic of South Africa. *A valid driver’s licence.
EXPERIENCE: * Minimum 8 years appropriate experience in relevant profession after registration with HPCSA (where applicable).
TECHNICAL PROFICIENCIES:
• Regulatory Sciences: *Knowledge or work experience with health product registration applications, or possibly with assessing the compiled applications. *Thorough understanding of the Regulatory environment that SAHPRA operates within (applicable legislation knowledge and understanding).
• Project Management: *Project Management experience within a Prince2, Agile, Scrum etc. framework. *Customer services experience/exposure.
CORE COMPETENCIES: *Effective Communication Skills. *Solid Leadership and Management Skills. *Ability to communicate complex technical concepts to non-technical stakeholders. *Solid Project Management experience. *Critical/Conceptual & Strategic thinking skills – allowing ICT strategies and business goals to be efficiently aligned. *High level of self-awareness. *Problem solving skills *Report writing skills. *Resilience. *Business Acumen. *Adaptability. *Solid Stakeholder management skills. *Solid Vendor management skills. *Knowledge and understanding of the Public Finance Management Act, including proven experience in its application. *Knowledge, understanding, and practical experience working in an ISO 9001 quality management systems environment.
RESPONSIBILITIES & DUTIES:
The role involves planning, project co-ordination, implementing, and maintaining all programme operational initiatives that will ensure effective management of applications, related records, reporting requirements, management of stakeholder and representing the HPA programme at senior management level and on external forums.
• Strategic Planning: *Develops an annual strategy, plan and budget (APP) for the division aligned with organisational needs and ensuring the most effective utilisation of resources.
• Team Management: *Leading and managing a team of IT professionals, including assigning tasks, providing guidance, concluding annual performance contracts, evaluating performance at mid-year and year-end, managing poor performance or disciplinary infractions, Leave Planning and management and fostering a collaborative work environment.
• Budgeting, Procurement and Resource Allocation: *Managing the HPA budget which includes submitting annual budget plan to Finance at communicated deadline and ensure that any/all planned CAPEX items and current and planned OPEX items are correctly accounted for, track and manage monthly expenses and revenue plan against budget to ensure overspend is avoided, revenue is collected in full in a timely manner, that team resources effectively allocated to complete work load within the operational area to manage work prioritise of the programme.
• Project Management: *Leading and managing identified and agreed HPA projects from start to finish, ensuring that projects are delivered on time, within budget, and meet stakeholders' requirements and related project governance structures and documentation is in place, including Project scope, project plans, Resource, Issues, Risks, Decisions and Quality registers and Project SteerCo with scheduled and minuted meetings. *Implement Project Management principles within the work streams to enable the Unit Manager(s), Portfolio Co-ordinators and Evaluator Co-ordinators to plan the work activities, co-ordinate support activities with the technical units, manage the resources in the workstream to ensure that ultimately, we progress rapidly with registration of new technologies and health products within identified target timelines.
• Stakeholder Management: *Cultivate and support Customer centric mindset within the HPA workstreams – ensuring that we follow our documented work practices to provide good and consistent service to all our stakeholders (internal and external)
Manage pro-active communication to various stakeholder groups to provide updates and pertinent information as it relates to HPA services and performance reporting.
• Training and Development: *Identifying training needs for HPA staff, organizing training programs, and promoting professional development to enhance the skills and knowledge of the HPA team. Ensure that all HPA Team members have been trained on all organisational policies and applicable standard operating procedures and guidelines and related proof of training/competence has been recorded and is on personnel file with HR.
• Continuous Improvement: *Staying updated on emerging operations and administrative trends within regulators, best practices, and regulatory requirements.
*Continuously evaluating and improving HPA work stream processes, systems, and policies to drive efficiency and effectiveness.
*Responding swiftly to any non-conformances or audit findings that are raised, ensure that that an Action plan and tracker is developed in collaboration with the whole HPA Team – detailing issue raised, responsible person, target due date, action to be taken and status of the open item. Ensuring that findings are closed with the 30-day timeline from when issue was raised to issue closed.
• Provide ad hoc support as discussed and instructed by the Chief Operations Officer: *Provide ad hoc support for additional tasks, as discussed, and instructed by the Chief Operating officer for interventions within the HPA functional area.
• Manage reporting requirements within communicated and agreed timelines: *Ensure that weekly HPA department meetings are set up with COO. Prepare and agenda for the weekly department meetings and provide the rolling tracker with updates the morning before the meeting to allow COO adequate time to prepare for the discussions. *Ensure committed activities are completed and reported on in sufficient detail. (Agenda broken up into 15 min to spend on new issues raised by manager, 30 min allocated rolling tracker update and last 15 min for COO to raise/update manager on new issues/matters). *Provide real-time updates to the COO on any matters that impact Key responsibility. *It is imperative that the HPA Manager keeps the COO abreast of events, deviations, performance related matters, incidents etc. that impact performance and service or might require escalated intervention. *Ensure that the quarterly HPA Performance Information Report and AOP reporting is submitted to the Business Planning Manner in accordance with communicated deadline and on the approved template. *Ensure that the quarterly TORS committee contribution is submitted to the Office Manager of the CRO in a timely manner so that the presentation can be submitted to TORS on time. *Develop and maintain any additional reports that may be required as a consequence of project related activities or ad hoc reports as requested from time to time. *Develop and maintain any operational report that is required to monitor the performance of the individual workstream teams.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 27 JULY 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
EVALUATOR COORDINATOR
Ref No.: SAHPRA 033/2023
SALARY: R692 830 – R737 929 p/a (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• Appropriate 3-year degree in a natural or health sciences, or B.Pharm.
• Minimum of five years’ work experience with at least 2 years in a medicine’s regulatory environment.
• Project Management experience will be an added advantage.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Sound working knowledge of document management and workflow management software. *Comfort working with computers and on a computer software packages. *Technical knowledge of the regulatory environment is an added bonus. *Knowledge of CTD and eCTD software applications is an added bonus.
Display exceptional stakeholder management capabilities. *Ability to communicate fluently in English with both written and verbal communication. *Defines and prioritizes goals in the face demands to keep people focused on achieving business objectives. *Good leadership and decision-making ability. *Critical thinking and problem-solving skills. *Planning and coordination skills. *Ability to manage conflict. *Ability to tolerate stress.
DUTIES:
Develop and consistently update staffing plan; * Record the experience and available capacity of evaluators (Record availability and ensure no idle time is detected for evaluators); * Define and document evaluator requirements in line with pre-determined KPIs by identifying the necessary skill level and capacity requirements for future batches of applications; * Allocate applications based on available evaluator experience and capacity to ensure evaluators are not overloaded; * Ensure that the application was correctly screened prior to allocation; * Ensure all the required templates required for evaluation are available.
Monthly reconciliation of applications assigned and successfully evaluated; * Monitor progress against predetermined KPIs, and identify the root causes for any shortfalls and implement solutions to remove these; * Oversee and update the Evaluator Coordinator (EC) tracker consistently to ensure traceability of applications and minimise allocation errors; * Assess and recommend the need for additional resources or expertise that may be required either for specific applications for the evaluation stream in general; * Reassign applications if necessary; * Liaise with Portfolio Coordinators regarding allocations of applications; * Liaise with evaluators regarding all issues on assigned work, e.g., evaluation-query clarification, etc; * Ensure open channels of communication with evaluators; * Ensure evaluators are kept informed of any updates/changes on issues that affect them; * Report on evaluator performance on an ongoing basis; * Review evaluator performance on an ongoing basis and determine training requirements, promotion or termination; * Continuously assess/review the peer review survey to determine an evaluator’s performance level; * Ensure timeous adherence of allocated work. * Troubleshoot any issues arising and escalate to management where necessary.
Timeously receive, audit and submit evaluator claim forms and invoices to the relevant payroll administrators; * Track, troubleshoot or report IT issues, and engage and liaise with IT where necessary on behalf of evaluators; * Track, troubleshoot or report HR issues, and engage and liaise with HR where necessary on behalf of evaluators; * Troubleshoot technical evaluation queries with the relevant Unit Manager; * Ensure availability of data for management reporting purposes as and when required (daily, weekly, monthly).
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the afore mentioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 July 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
EVALUATOR COORDINATOR
Ref No.: SAHPRA 033/2023
SALARY: R692 830 – R737 929 p/a (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• Appropriate 3-year degree in a natural or health sciences, or B.Pharm.
• Minimum of five years’ work experience with at least 2 years in a medicine’s regulatory environment.
• Project Management experience will be an added advantage.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Sound working knowledge of document management and workflow management software. *Comfort working with computers and on a computer software packages. *Technical knowledge of the regulatory environment is an added bonus. *Knowledge of CTD and eCTD software applications is an added bonus.
Display exceptional stakeholder management capabilities. *Ability to communicate fluently in English with both written and verbal communication. *Defines and prioritizes goals in the face demands to keep people focused on achieving business objectives. *Good leadership and decision-making ability. *Critical thinking and problem-solving skills. *Planning and coordination skills. *Ability to manage conflict. *Ability to tolerate stress.
DUTIES:
Develop and consistently update staffing plan; * Record the experience and available capacity of evaluators (Record availability and ensure no idle time is detected for evaluators); * Define and document evaluator requirements in line with pre-determined KPIs by identifying the necessary skill level and capacity requirements for future batches of applications; * Allocate applications based on available evaluator experience and capacity to ensure evaluators are not overloaded; * Ensure that the application was correctly screened prior to allocation; * Ensure all the required templates required for evaluation are available.
Monthly reconciliation of applications assigned and successfully evaluated; * Monitor progress against predetermined KPIs, and identify the root causes for any shortfalls and implement solutions to remove these; * Oversee and update the Evaluator Coordinator (EC) tracker consistently to ensure traceability of applications and minimise allocation errors; * Assess and recommend the need for additional resources or expertise that may be required either for specific applications for the evaluation stream in general; * Reassign applications if necessary; * Liaise with Portfolio Coordinators regarding allocations of applications; * Liaise with evaluators regarding all issues on assigned work, e.g., evaluation-query clarification, etc; * Ensure open channels of communication with evaluators; * Ensure evaluators are kept informed of any updates/changes on issues that affect them; * Report on evaluator performance on an ongoing basis; * Review evaluator performance on an ongoing basis and determine training requirements, promotion or termination; * Continuously assess/review the peer review survey to determine an evaluator’s performance level; * Ensure timeous adherence of allocated work. * Troubleshoot any issues arising and escalate to management where necessary.
Timeously receive, audit and submit evaluator claim forms and invoices to the relevant payroll administrators; * Track, troubleshoot or report IT issues, and engage and liaise with IT where necessary on behalf of evaluators; * Track, troubleshoot or report HR issues, and engage and liaise with HR where necessary on behalf of evaluators; * Troubleshoot technical evaluation queries with the relevant Unit Manager; * Ensure availability of data for management reporting purposes as and when required (daily, weekly, monthly).
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the afore mentioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 July 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
LABOUR RELATIONS SPECIALIST
Ref No.: SAHPRA 029/2023
SALARY: R1 126 846 – R1 196 011 p/a (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• Appropriate Tertiary qualification bachelor’s degree or National Diploma in Labour Law, Human Resources or related field with at least 5 years relevant experience preferably in the public sector.
• Proven track record in an Employee Relations / Industrial Relations role.
• Labour Relations Specialist experience corporate labour relations and CCMA / Bargaining Council representation. Demonstrated knowledge of employment and labour laws.
• Knowledge of and ability to interpret Human Resources Management Framework with specific reference to labour relations.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: *Knowledge and understanding of the Public Finance Management Act and labour legislation, including proven experience in application thereof; *Ability to work under stress and to meet tight deadlines; *Analytical and problem-solving skills; *Verbal and written communication skills; *Ability to work independently without guidance, and in a team; *Resilience; *Communication skills (verbal, written, negotiation, conflict management, presentation); *Interpersonal skills; *Ethical behaviour; *Customer service; *Planning and organising skills; *Negotiation skills.
DUTIES:
LABOUR RELATIONS ADVICE AND TRAINING
• Responsible and accountable for the development of SAHPRA’s Labour Relations and/or Industrial Relations strategy and Policies, supported by the guidelines and/or the SOPs as guided by legislation.
• Guide, coach and train line managers and employees on disciplinaries, grievances and performance management processes.
• Guide and advice line managers on disciplinary hearings, internal grievances, incapacities processes and mediation to ensure disputes are resolved in line with legislative requirements as well adherence with internal SAHPRA policies and procedures.
• Labour Relations training sessions and workshops for Line Management by conducting labour law updates for the SAHPRA to keep the business abreast of latest case law and juris-prudence and by assisting in the formulation and execution of approved Labour Relations programmes, policies, related training and support programmes to ensure to up skill line management on effective management of Labour Relations matters for the SAHPRA
STAKEHOLDER / RELATIONSHIP MANAGEMENT
• Must create a sustainable relationships with key stakeholders in collaboration with the HR TEAM and maintain a good working relationship with the Labour Leadership and Senior Managers within SAHPRA, by actively driving and chairing Consultative Forums and SAHPRA leadership engagements
• Lead and direct the annual substantive negotiations with Organized Labour as per the Public Health and Social Development Sectoral Bargaining Council (PHSDSBC) and by representing the SAHPRA at Labour Related engagements to ensure that recognition agreements are aligned with business strategy and amended where applicable.
• The incumbent may be requested to represent SAHPRA to other utilities when they need support in their interviews or other engagements.
• Facilitates and monitors the establishment of relevant internal labour committees.
DISPUTE RESOLUTION and LABOUR RELATIONS STRATEGIC PROJECTS
• Lead and drive the preparation for CCMA Arbitrations / Corn Arbs and Labour Court Case processes by representing SAHPRA in dispute mediation within the area of responsibility through participation in evidence investigative processes with line management, Forensics and other key stakeholders to the dispute to ensure disputes are resolved in line with legislative requirements.
• Lead and drive the delivery of Labour Relations projects and strategic initiatives and assist in the implementation of appropriate action plans in conjunction with the HR Team, line management and other relevant stakeholders to ensure delivery in line with business and legislative requirements while establishing adequate Labour Relations emergency plans to mitigate potential ER/IR risks.
• Ensure SAHPRA is compliant with employment laws.
• The position holder develops and ensures that all reports on Labour Relations / Industrial Relations are made available to be presented to stakeholders, when necessary.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 July 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
LABOUR RELATIONS SPECIALIST
Ref No.: SAHPRA 029/2023
SALARY: R1 126 846 – R1 196 011 p/a (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• Appropriate Tertiary qualification bachelor’s degree or National Diploma in Labour Law, Human Resources or related field with at least 5 years relevant experience preferably in the public sector.
• Proven track record in an Employee Relations / Industrial Relations role.
• Labour Relations Specialist experience corporate labour relations and CCMA / Bargaining Council representation. Demonstrated knowledge of employment and labour laws.
• Knowledge of and ability to interpret Human Resources Management Framework with specific reference to labour relations.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: *Knowledge and understanding of the Public Finance Management Act and labour legislation, including proven experience in application thereof; *Ability to work under stress and to meet tight deadlines; *Analytical and problem-solving skills; *Verbal and written communication skills; *Ability to work independently without guidance, and in a team; *Resilience; *Communication skills (verbal, written, negotiation, conflict management, presentation); *Interpersonal skills; *Ethical behaviour; *Customer service; *Planning and organising skills; *Negotiation skills.
DUTIES:
LABOUR RELATIONS ADVICE AND TRAINING
• Responsible and accountable for the development of SAHPRA’s Labour Relations and/or Industrial Relations strategy and Policies, supported by the guidelines and/or the SOPs as guided by legislation.
• Guide, coach and train line managers and employees on disciplinaries, grievances and performance management processes.
• Guide and advice line managers on disciplinary hearings, internal grievances, incapacities processes and mediation to ensure disputes are resolved in line with legislative requirements as well adherence with internal SAHPRA policies and procedures.
• Labour Relations training sessions and workshops for Line Management by conducting labour law updates for the SAHPRA to keep the business abreast of latest case law and juris-prudence and by assisting in the formulation and execution of approved Labour Relations programmes, policies, related training and support programmes to ensure to up skill line management on effective management of Labour Relations matters for the SAHPRA
STAKEHOLDER / RELATIONSHIP MANAGEMENT
• Must create a sustainable relationships with key stakeholders in collaboration with the HR TEAM and maintain a good working relationship with the Labour Leadership and Senior Managers within SAHPRA, by actively driving and chairing Consultative Forums and SAHPRA leadership engagements
• Lead and direct the annual substantive negotiations with Organized Labour as per the Public Health and Social Development Sectoral Bargaining Council (PHSDSBC) and by representing the SAHPRA at Labour Related engagements to ensure that recognition agreements are aligned with business strategy and amended where applicable.
• The incumbent may be requested to represent SAHPRA to other utilities when they need support in their interviews or other engagements.
• Facilitates and monitors the establishment of relevant internal labour committees.
DISPUTE RESOLUTION and LABOUR RELATIONS STRATEGIC PROJECTS
• Lead and drive the preparation for CCMA Arbitrations / Corn Arbs and Labour Court Case processes by representing SAHPRA in dispute mediation within the area of responsibility through participation in evidence investigative processes with line management, Forensics and other key stakeholders to the dispute to ensure disputes are resolved in line with legislative requirements.
• Lead and drive the delivery of Labour Relations projects and strategic initiatives and assist in the implementation of appropriate action plans in conjunction with the HR Team, line management and other relevant stakeholders to ensure delivery in line with business and legislative requirements while establishing adequate Labour Relations emergency plans to mitigate potential ER/IR risks.
• Ensure SAHPRA is compliant with employment laws.
• The position holder develops and ensures that all reports on Labour Relations / Industrial Relations are made available to be presented to stakeholders, when necessary.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 July 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
MEDICINE REGISTRATION OFFICER: CLINICAL TRIALS x3
Salary: R788 910 – R837 326 p/a (Total Cost to Company)
Ref No.: SAHPRA 028/2023
CENTRE: Pretoria
REQUIREMENTS: ● Appropriate 4-year Bachelor of Pharmacy Degree from a recognised university or tertiary institution. A post graduate qualification in Health Science (NQF 9 Level is a strong recommendation. ●Registration as a Pharmacist with the South African Pharmacy Council (SAPC).
Experience: ● A minimum of at least 8 years’ experience.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: * Knowledge and application of the Medicines and Related Substances Act (101 of 1965) as amended and its related Regulations and Guidelines. * Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. * Knowledge of technical aspects for evaluation of quality and efficacy (bioequivalence) of medicines. * Evaluation guidelines as prescribed by the relevant regulatory authorities. * Technical and scientific aspects of medicine regulation. * Self-motivated and able to work independently. * Competent in problem solving and team building. * Information evaluation. * Computer literacy and sound working knowledge of computer software packages. * Planning and organisational skills. * Leadership skills. * Coordination skills. * Written and verbal communication skills. * Diversity management. * Time management. * Good telephone etiquette. * Supervisory skills. * Must be willing to travel and work irregular hours when so required. *A valid driver’s licence.
DUTIES:
Technical screening of new clinical trial applications to ensure adherence to SAHPRA requirements; * Technical Evaluation of applications to conduct clinical trial applications; * Provide recommendations on review of applications to Clinical Trials Expert Committee / SAHPRA; * Review applicant responses and recommend for approval or rejection of clinical trial applications; * Communicate the recommendations queries, approval or non-approval to the Applicants; * Communicate with other units: medical device, complementary unit or inspectorate and regulatory compliance on referred Clinical Trial applications; * Communicate with the finance unit on acceptability of the documentation on clinical trial applications, if required and resolve queries from finance; * Complete/Ensure completion of the status tracker to ensure timely reporting (Finance, performance and WHO); * Manage submission of clinical trial application cycles.
Technical screening of new Bioequivalence studies to ensure adherence to SAHPRA requirements; * Technical Review of Bioequivalence studies applications; * Provide recommendations on applications to Authority (Clinical Trials Expert Committee, if required); * Review applicant responses and recommend for approval or rejection of Bioequivalence studies; * Communicate the recommendations, approval or non-approval to the Applicants; * Complete/Ensure completion of the status tracker to ensure timely finance and performance reporting; * Manage submission of Bioequivalence from receipt to finalization; * Allocate clinical trials to the external evaluators in accordance with expert areas; * Co-ordinate clinical trials applications and monitor progress of review (follow up with external evaluators); * Liaise advisory committee members and external reviewers; * Prepare agenda and documentation to serve at the Clinical Trials Expert Committee; * Support the proceeding of the Clinical Trial Committee meetings, including the expert consultation meetings; * Prepare minutes and recommendations following the meeting of the Clinical trials expert committee; * Evaluate and provide opinion on performance of external expert reviewer; * Communicate the recommendations to the external stakeholder following the Clinical Trials Committee meetings.
Review Serious Adverse Events (SAE) reports, progress reports and other safety reports during the Conduct of Clinical Trials and Bioequivalence studies; * Validate the SAE report on the system after review; * Present the SAE Reports to Clinical Trials Safety Monitoring Committee / Clinical Trial Committee on critical findings; * Set up systems and advise on implementation of the process of SAE reporting; * Advise on improvement of system or any other processes in the Unit; * Communicate with other units: PV, medical device, complementary unit or inspectorate and regulatory compliance on matters during review of safety reports; * Liaise with advisory committee members Clinical Trials Safety Monitoring Committee; * Prepare agenda and documentation to serve at the Clinical Trials Safety Monitoring Committee; * Support the proceeding of the Clinical Trial Committee meetings; * Prepare minutes and recommendations following the meeting of the Clinical Trials Safety Monitoring Committee; * Communicate the recommendations to the external stakeholder following the Clinical Trials Committee meetings.
Screening and technical review of applications for protocol amendments in line with set timelines in annual operations plan; * Allocation of clinical trials protocol amendment to the external evaluators in accordance with expert areas; * Advise on improvement of system or any other processes in the Unit; * Check the status of all applications received to monitor timeline in line with Annual performance plan or annual operations plan; * Respond and attend to queries and complaints timely related to applications from external stakeholder; * Update spreadsheet on regular basis. Provide statistics on applications reviewed and outstanding in preparation for monthly finance and performance reporting; * Review investigators, change in investigators/Principal investigators or additional sites in line with the set timelines; * Check the status of all applications received to monitor timeline in line with Annual performance plan or annual operations plan; * Advice by responding to queries and complaints timely related to applications from external stakeholder; * Advise on improvement of system or any other processes in the Unit. *Update spreadsheet on regular basis; * Provide statistics on applications reviewed and outstanding in preparation for monthly finance and performance reporting.
Drafting and review of policies and Preparation of Policy document; * Develop SOPs, review SoPs and ensure availability of SOPs at a point of service. *Ensures the business unit complies with the approved Standard Operating Procedures; * Manage Admin staff to ensure compliance with timelines and attend to queries; * Perform Performance assessment of admin staff; * Investigate and advise pharmaceutical industry / applicant’s queries or other members of the Public; *Manage resolution of the queries in area of work; * Provide advice or recommend to inspectorate or regulatory compliance unit; * Represent SAHPRA in the local, regional and/or global sphere; * Arrange and attend Industry Task Group working groups and external stakeholder meetings; * Attend and support the internal and external Audit, including resolution of queries. *Manage and keep records regularly of clinical trial related activities.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 July 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
MEDICINE REGISTRATION OFFICER: CLINICAL TRIALS x3
Salary: R788 910 – R837 326 p/a (Total Cost to Company)
Ref No.: SAHPRA 028/2023
CENTRE: Pretoria
REQUIREMENTS: ● Appropriate 4-year Bachelor of Pharmacy Degree from a recognised university or tertiary institution. A post graduate qualification in Health Science (NQF 9 Level is a strong recommendation. ●Registration as a Pharmacist with the South African Pharmacy Council (SAPC).
Experience: ● A minimum of at least 8 years’ experience.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: * Knowledge and application of the Medicines and Related Substances Act (101 of 1965) as amended and its related Regulations and Guidelines. * Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. * Knowledge of technical aspects for evaluation of quality and efficacy (bioequivalence) of medicines. * Evaluation guidelines as prescribed by the relevant regulatory authorities. * Technical and scientific aspects of medicine regulation. * Self-motivated and able to work independently. * Competent in problem solving and team building. * Information evaluation. * Computer literacy and sound working knowledge of computer software packages. * Planning and organisational skills. * Leadership skills. * Coordination skills. * Written and verbal communication skills. * Diversity management. * Time management. * Good telephone etiquette. * Supervisory skills. * Must be willing to travel and work irregular hours when so required. *A valid driver’s licence.
DUTIES:
Technical screening of new clinical trial applications to ensure adherence to SAHPRA requirements; * Technical Evaluation of applications to conduct clinical trial applications; * Provide recommendations on review of applications to Clinical Trials Expert Committee / SAHPRA; * Review applicant responses and recommend for approval or rejection of clinical trial applications; * Communicate the recommendations queries, approval or non-approval to the Applicants; * Communicate with other units: medical device, complementary unit or inspectorate and regulatory compliance on referred Clinical Trial applications; * Communicate with the finance unit on acceptability of the documentation on clinical trial applications, if required and resolve queries from finance; * Complete/Ensure completion of the status tracker to ensure timely reporting (Finance, performance and WHO); * Manage submission of clinical trial application cycles.
Technical screening of new Bioequivalence studies to ensure adherence to SAHPRA requirements; * Technical Review of Bioequivalence studies applications; * Provide recommendations on applications to Authority (Clinical Trials Expert Committee, if required); * Review applicant responses and recommend for approval or rejection of Bioequivalence studies; * Communicate the recommendations, approval or non-approval to the Applicants; * Complete/Ensure completion of the status tracker to ensure timely finance and performance reporting; * Manage submission of Bioequivalence from receipt to finalization; * Allocate clinical trials to the external evaluators in accordance with expert areas; * Co-ordinate clinical trials applications and monitor progress of review (follow up with external evaluators); * Liaise advisory committee members and external reviewers; * Prepare agenda and documentation to serve at the Clinical Trials Expert Committee; * Support the proceeding of the Clinical Trial Committee meetings, including the expert consultation meetings; * Prepare minutes and recommendations following the meeting of the Clinical trials expert committee; * Evaluate and provide opinion on performance of external expert reviewer; * Communicate the recommendations to the external stakeholder following the Clinical Trials Committee meetings.
Review Serious Adverse Events (SAE) reports, progress reports and other safety reports during the Conduct of Clinical Trials and Bioequivalence studies; * Validate the SAE report on the system after review; * Present the SAE Reports to Clinical Trials Safety Monitoring Committee / Clinical Trial Committee on critical findings; * Set up systems and advise on implementation of the process of SAE reporting; * Advise on improvement of system or any other processes in the Unit; * Communicate with other units: PV, medical device, complementary unit or inspectorate and regulatory compliance on matters during review of safety reports; * Liaise with advisory committee members Clinical Trials Safety Monitoring Committee; * Prepare agenda and documentation to serve at the Clinical Trials Safety Monitoring Committee; * Support the proceeding of the Clinical Trial Committee meetings; * Prepare minutes and recommendations following the meeting of the Clinical Trials Safety Monitoring Committee; * Communicate the recommendations to the external stakeholder following the Clinical Trials Committee meetings.
Screening and technical review of applications for protocol amendments in line with set timelines in annual operations plan; * Allocation of clinical trials protocol amendment to the external evaluators in accordance with expert areas; * Advise on improvement of system or any other processes in the Unit; * Check the status of all applications received to monitor timeline in line with Annual performance plan or annual operations plan; * Respond and attend to queries and complaints timely related to applications from external stakeholder; * Update spreadsheet on regular basis. Provide statistics on applications reviewed and outstanding in preparation for monthly finance and performance reporting; * Review investigators, change in investigators/Principal investigators or additional sites in line with the set timelines; * Check the status of all applications received to monitor timeline in line with Annual performance plan or annual operations plan; * Advice by responding to queries and complaints timely related to applications from external stakeholder; * Advise on improvement of system or any other processes in the Unit. *Update spreadsheet on regular basis; * Provide statistics on applications reviewed and outstanding in preparation for monthly finance and performance reporting.
Drafting and review of policies and Preparation of Policy document; * Develop SOPs, review SoPs and ensure availability of SOPs at a point of service. *Ensures the business unit complies with the approved Standard Operating Procedures; * Manage Admin staff to ensure compliance with timelines and attend to queries; * Perform Performance assessment of admin staff; * Investigate and advise pharmaceutical industry / applicant’s queries or other members of the Public; *Manage resolution of the queries in area of work; * Provide advice or recommend to inspectorate or regulatory compliance unit; * Represent SAHPRA in the local, regional and/or global sphere; * Arrange and attend Industry Task Group working groups and external stakeholder meetings; * Attend and support the internal and external Audit, including resolution of queries. *Manage and keep records regularly of clinical trial related activities.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 July 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
SENIOR ADMINISTRATION OFFICER
Ref No.: SAHPRA 034/2023
SALARY: R384 936 – R408 560 p/a (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• An appropriate 3-year National Diploma/Degree
• A minimum of 3 years work experience in administration and/or data management
• Supervisory experience will be an added advantage
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Strong administrative and organizational skills. * Willingness to work extended hours as and when required. * Ability to communicate fluently in English with both written and spoken communication. * Good leadership and decision-making ability. * Critical thinking and problem-solving skills. * Planning and coordination skills. * Ability to manage conflict. * Ability to work under pressure. * Deadline driven. * Attention to detail. * Versatility. * Innovative thinking. * Supervisory skills. * Team player and can work independently. * Ability to work well under pressure.
DUTIES:
Ensure that the renewal applications are uploaded and synced to the evaluating system; * Receive and sort renewal applications and responses. * Verify that all renewal and response applications received are uploaded to the evaluating system. * Perform administrative screening accurately according to the checklist. * Upload application number letter, proof of payment, working documents and completed query template to the application file plan. * Monitor work output by recording statistics. * Resolving/escalate queries from internal or external stakeholders. * Develop a file plan for performance data to ensure accessibility. * Assist the audit processes in collaboration with quality management and finance units. * Maintain the master applications database by:
• Capturing information on renewal applications tracker on receipt of the application
• Updating tracker routinely to ensure information is current
Develop standard operating procedures (SOP’s) for the renewal administrative functions and ensure compliance. * Check that the proof of payments are valid and correct. * Collating of revenue information for Finance each month (Application letters, Proofs of payment, and Approval letters). * Compile renewal administrative reports (monthly and quarterly) for the Portfolio Coordinator. * Receive the template of the renewal certificate from the applicant. * Check the renewal certificate for correctness and amend as necessary. * Liaise with applicant regarding corrections to the certificate. * Co-ordinate the process of CEO sign-off of certificates and the subsequent distribution to applicants. * Address renewal certificate queries from internal and external stakeholders in a timely and professional manner. * Keep statistics for renewal certificates and forward to Portfolio Coordinator for the quarterly reports. * Archive the copy of the renewal certificate. * Update the medicine register database.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 July 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
SENIOR ADMINISTRATION OFFICER
Ref No.: SAHPRA 034/2023
SALARY: R384 936 – R408 560 p/a (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• An appropriate 3-year National Diploma/Degree
• A minimum of 3 years work experience in administration and/or data management
• Supervisory experience will be an added advantage
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Strong administrative and organizational skills. * Willingness to work extended hours as and when required. * Ability to communicate fluently in English with both written and spoken communication. * Good leadership and decision-making ability. * Critical thinking and problem-solving skills. * Planning and coordination skills. * Ability to manage conflict. * Ability to work under pressure. * Deadline driven. * Attention to detail. * Versatility. * Innovative thinking. * Supervisory skills. * Team player and can work independently. * Ability to work well under pressure.
DUTIES:
Ensure that the renewal applications are uploaded and synced to the evaluating system; * Receive and sort renewal applications and responses. * Verify that all renewal and response applications received are uploaded to the evaluating system. * Perform administrative screening accurately according to the checklist. * Upload application number letter, proof of payment, working documents and completed query template to the application file plan. * Monitor work output by recording statistics. * Resolving/escalate queries from internal or external stakeholders. * Develop a file plan for performance data to ensure accessibility. * Assist the audit processes in collaboration with quality management and finance units. * Maintain the master applications database by:
• Capturing information on renewal applications tracker on receipt of the application
• Updating tracker routinely to ensure information is current
Develop standard operating procedures (SOP’s) for the renewal administrative functions and ensure compliance. * Check that the proof of payments are valid and correct. * Collating of revenue information for Finance each month (Application letters, Proofs of payment, and Approval letters). * Compile renewal administrative reports (monthly and quarterly) for the Portfolio Coordinator. * Receive the template of the renewal certificate from the applicant. * Check the renewal certificate for correctness and amend as necessary. * Liaise with applicant regarding corrections to the certificate. * Co-ordinate the process of CEO sign-off of certificates and the subsequent distribution to applicants. * Address renewal certificate queries from internal and external stakeholders in a timely and professional manner. * Keep statistics for renewal certificates and forward to Portfolio Coordinator for the quarterly reports. * Archive the copy of the renewal certificate. * Update the medicine register database.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 July 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
SERVICE DESK COORDINATOR
Ref No.: SAHPRA 031/2023
SALARY: R384 936 – R408 560 p/a (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• Relevant National Diploma or similar (NQF Level 6)
• At least 2 to 3 years of Service Desk Coordinator experience.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Basic Computer troubleshooting skills. * Ability to diagnose and resolve basic technical issues. * Willingness to work extended hours as and when required. * Ability to communicate at all levels. * Deadline driven. * Attention to detail. * Versatility. * Team player and able to work independently. * Supervisory skills
DUTIES:
• Administer and coordinate IT Service Desk (IT Helpdesk) requests, logged incidents, activities and tasks.
• Being responsible for coordinating consistent response, communication and delivery of IT Support and Service requests.
• Open and review Service Desk calls; ensuring the user/requester provides an appropriate level of information.
• Allocate Service Desk Calls to appropriate technician/team and trigger appropriate escalations.
• Ensure that Service Desk Calls are monitored in-line with SLAs and updated efficiently and effectively.
• Proactively communicate with the users in order to provide updates on outstanding incidents and requests.
• Build and maintain strong working relationships with key business users, colleagues, and support bodies in order to provide a professional customer service approach.
• Work positively and communicate professionally across teams in order to make an effective contribution to team tasks and team spirit.
• Pass on any feedback for suggestions by end-users to the appropriate internal team.
• Provide first line technical support by providing telephonic or remote assistance.
• Direct unresolved issues to the next level of support personnel.
• Assist in the investigation and resolution of issues relating to applications to assist the team in providing a high level of customer service.
• Analyse requests and incidents to identify patterns or problems and escalate the 2nd line support teams.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 July 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
SERVICE DESK COORDINATOR
Ref No.: SAHPRA 031/2023
SALARY: R384 936 – R408 560 p/a (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• Relevant National Diploma or similar (NQF Level 6)
• At least 2 to 3 years of Service Desk Coordinator experience.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Basic Computer troubleshooting skills. * Ability to diagnose and resolve basic technical issues. * Willingness to work extended hours as and when required. * Ability to communicate at all levels. * Deadline driven. * Attention to detail. * Versatility. * Team player and able to work independently. * Supervisory skills
DUTIES:
• Administer and coordinate IT Service Desk (IT Helpdesk) requests, logged incidents, activities and tasks.
• Being responsible for coordinating consistent response, communication and delivery of IT Support and Service requests.
• Open and review Service Desk calls; ensuring the user/requester provides an appropriate level of information.
• Allocate Service Desk Calls to appropriate technician/team and trigger appropriate escalations.
• Ensure that Service Desk Calls are monitored in-line with SLAs and updated efficiently and effectively.
• Proactively communicate with the users in order to provide updates on outstanding incidents and requests.
• Build and maintain strong working relationships with key business users, colleagues, and support bodies in order to provide a professional customer service approach.
• Work positively and communicate professionally across teams in order to make an effective contribution to team tasks and team spirit.
• Pass on any feedback for suggestions by end-users to the appropriate internal team.
• Provide first line technical support by providing telephonic or remote assistance.
• Direct unresolved issues to the next level of support personnel.
• Assist in the investigation and resolution of issues relating to applications to assist the team in providing a high level of customer service.
• Analyse requests and incidents to identify patterns or problems and escalate the 2nd line support teams.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 July 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
TECHNICAL SCREENER x 3
Ref No.: SAHPRA 032/2023
SALARY: R473 552 – R502 629 p/a (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• Appropriate 4-year degree in Chemistry/Pharmacology or Bachelor of Pharmacy
• Minimum of 3 years relevant medicines regulatory experience
• Experience in product review or assessments will be an added advantage
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Theoretical knowledge of technical aspects for evaluation of medicines across all fields, namely: *Safety and efficacy, *Quality and bioequivalence, *Naming and scheduling, *Good manufacturing Practice.
Comfort working with computers and on a computer software packages. *Displays a strong academic background. *Ability to communicate fluently in English with both written and verbal communication. *Ability to work precisely and efficiently. *Able to remain self-motivated with the ability to work independently. *Ability to prioritize and displays excellent time management skills. *Knowledge of the regulatory environment. *Positive attitude
DUTIES:
Assess each module of the application against the relevant technical screening form to ensure they are appropriate in terms of format and content as defined by the relevant guidelines; * Verify and confirm that the proof of payment is valid and correct; * Generate a list of queries to the applicant using the correct templates; * Technical screening outcome report should be signed and dated; * Technical screening should be completed within target timelines; * Submit the generated list of queries to another technical screener for peer review; *Communicate the technical screening outcome to an Evaluator Co-ordinator for upload to the relevant platform
for technical Manager’s signature; * Capture outcome of the screening and completion date on the Tracker; * Classify applications according to Pharmacological Classification; * Classify application into Generics, New Chemical Entities, Biosimilars, and Vaccines;* Peer-review technical screening report (s) done by other technical screeners; * Assess query responses to confirm compliance; * Generate rejection letter for applications not compliant with applicable guidelines; * Provide relevant statistics and evidence for Performance Reporting; * Identify and report on trends for decision making.
Assess each relevant module of the application against the relevant technical screening form to ensure they are appropriate in terms of format and content as defined by the relevant guidelines; * Verify and confirm that the proof of payment is valid and correct; * Generate a list of queries to the applicant using the correct template; * Technical screening outcome report should be signed and dated; * Technical screening should be completed within target timelines; * Submit the generated list of queries to another technical screener for peer review; * Communicate the technical screening outcome to an EC for upload to the relevant platform for technical Manager’s signature; * Capture outcome of the screening and completion date on the Tracker; * Assess and classify the type of variation application; * Timeous assessment and identification of medicine safety issues or signals stemming from pharmacovigilance recommendations; *Assess query responses to confirm compliance; * Generate rejection letter for applications not compliant with applicable guidelines; * Provide relevant statistics and evidence for Performance Reporting; *Identify and report on trends for decision making.
Verify and confirm that the correct and relevant documents are submitted for the selected review pathway; * Source reliance reports from the relevant Recognised Regulatory Authority (RRA) via the focal person; * Save the relevant reports in the folder structure for the specific application; * Capture details of the review pathway on the screening outcome report and on the Tracker; * Identify and confirm applications for internal reliance and capture on the screening outcome report and on the Tracker; * Standard operating procedures and guidelines must be adhered to; * Attend relevant training as may be necessary to support your function; * Provide weekly progress reports to the relevant Portfolio Co-ordinator.
INSTRUCTIONS TO APPLICANTS: All applications must:
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 July 2023 at 16H00.