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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.
MEDICINE REGISTRATION OFFICER: VIGILANCE
(CLINICAL EVALUATION MANAGEMENT)
Salary: R692 830.00 – R837 326.00 p/a (All-inclusive)
Ref No.: SAHPRA 011/2023
CENTRE: Pretoria
REQUIREMENTS: ● Appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with the South African Pharmacy Council (SAPC) - (Proof of registration [Current Designation Letter] must accompany the application).
Experience: ● Maximum of 7 years proven relevant experience (post community service).
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. * Sound knowledge of regulatory scientific and technical requirements (in terms of quality, safety and efficacy aspect). *Knowledge of Good Pharmacovigilance Practice. * Comprehensive knowledge and understanding of the international regulators. * Knowledge of MS Office. * Computer skills. * Planning and organising skills. * Drive and self-management skills. * Communication skills (verbal, written, conflict management, presentation). * Ability to work in a highly pressured environment and driven by a sense of urgency to meet deadlines. *Assertiveness. * Ethical behaviour. * Prepared to travel and work irregular hours. *A valid driver’s licence.
DUTIES: ● Evaluate safety related submissions and responses thereof. ● Co-ordinate Pharmacovigilance activities and Committee meetings. ● Supervise administrative staff and attend to queries addressed to the Pharmacovigilance Unit. ● Provide technical assistance and support to appropriate Advisory Committee/s and SAHPRA generally. ● Develop Standard Operating Procedures (SOPs), related policies and guidelines pertaining to Pharmacovigilance activities. ● Promote vigilance by collecting, managing, and assessing ADR and medication error reports including post-marketing surveillance and research data. ● Create and promote PV awareness and education amongst reporters regarding the significance/importance of reporting ADRs and the use of the reporting tools. ● Collaborate with different stakeholders to strengthen PV within the country. ● Evaluate and communicate vigilance related issues. ● Perform other related functions that may arise from time to time.
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: 01 March 2023 at 16H00.
MEDICINE REGISTRATION OFFICER: VIGILANCE
(CLINICAL EVALUATION MANAGEMENT)
Salary: R692 830.00 – R837 326.00 p/a (All-inclusive)
Ref No.: SAHPRA 011/2023
CENTRE: Pretoria
REQUIREMENTS: ● Appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with the South African Pharmacy Council (SAPC) - (Proof of registration [Current Designation Letter] must accompany the application).
Experience: ● Maximum of 7 years proven relevant experience (post community service).
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. * Sound knowledge of regulatory scientific and technical requirements (in terms of quality, safety and efficacy aspect). *Knowledge of Good Pharmacovigilance Practice. * Comprehensive knowledge and understanding of the international regulators. * Knowledge of MS Office. * Computer skills. * Planning and organising skills. * Drive and self-management skills. * Communication skills (verbal, written, conflict management, presentation). * Ability to work in a highly pressured environment and driven by a sense of urgency to meet deadlines. *Assertiveness. * Ethical behaviour. * Prepared to travel and work irregular hours. *A valid driver’s licence.
DUTIES: ● Evaluate safety related submissions and responses thereof. ● Co-ordinate Pharmacovigilance activities and Committee meetings. ● Supervise administrative staff and attend to queries addressed to the Pharmacovigilance Unit. ● Provide technical assistance and support to appropriate Advisory Committee/s and SAHPRA generally. ● Develop Standard Operating Procedures (SOPs), related policies and guidelines pertaining to Pharmacovigilance activities. ● Promote vigilance by collecting, managing, and assessing ADR and medication error reports including post-marketing surveillance and research data. ● Create and promote PV awareness and education amongst reporters regarding the significance/importance of reporting ADRs and the use of the reporting tools. ● Collaborate with different stakeholders to strengthen PV within the country. ● Evaluate and communicate vigilance related issues. ● Perform other related functions that may arise from time to time.
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: 01 March 2023 at 16H00.
MANAGER: Business Planning and Performance Monitoring
Salary: SMS Level 13 (R1 073 187)
Ref No.: SAHPRA 005/2023
CENTRE: Pretoria
REQUIREMENTS: B. Comm or Business Administration Degree or equivalent as a minimum. A Post graduate qualification will be advantageous. Business Analyst certification or Project Management certification will be advantageous.
Experience: Minimum of 3 years’ experience in business performance monitoring and evaluation at a managerial level.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: *Analytical skills: The ability to analyze situations and to arrive at the best possible solution. *Facilitation skills: The ability to facilitate events and interventions to achieve the best possible results. *Interpersonal: The ability to interact with people at all levels in the organization. *Problem solving: The ability to apply the principles of problem-solving techniques to identify and resolve a problem in the best interest of all stakeholders. *Negotiation skills: The ability to negotiate with role players and arrive at a win-win situation in the best interest of the organisation and the negotiating party. *Time Management skills: The ability to manage time effectively and efficiently in accordance with work priorities to ensure qualitative outcomes. *Communication skills: The ability to communicate effectively and efficiently at all levels in the organization. *Presentation skills: The ability to conduct presentations at all levels in the organisation with and without presentation aids. *Reporting skills: The ability to accurately give an account of information pertaining to the performance of outputs. *Management: The ability to plan, organize, lead and control in the work environment to achieve the business objectives. *Organizing: To apply or impose efficient working methods in order to work effectively or make somebody else work effectively.
DUTIES: Strategic Business Planning *Development of the Strategic Plan document and Annual Performance Plan document for the entity. *Conduct workshops to obtain inputs to the Operational Plan documents with all business units. *Supports the development of business unit’s operational plan documents to ensure objectives are realistic and measurable. *Ensure alignment of business units' deliverables with SAHPRA’s strategic goals.
Performance Monitoring *Design and implement/improve performance monitoring guidelines, templates and processes. *Gather and evaluate performance information monthly, quarterly and annually from the business units and provide analytics insights to the relevant Executives through management dashboards & reports. Specifically focus on deviations and corrective action plans to course-correct to achieve performance targets*Coordinate monitoring and evaluation of performance against the business unit’s operational plans. *Ensure accurate response to audit queries on business performance before they become findings. *Identify, manage and coordinate the implementation of knowledge systems, tools and initiatives to improve business monitoring and evaluation. *Collection and verification of performance evidence as necessary.
Business Performance Reporting *Compile business performance reports as guided by legislation (National Department of Health and Department of Planning, Monitoring and Evaluation). * Collate information from business units, synthesise and ensure the completion of quarterly and annual reporting. *Prepare and update the annual performance report for presenting to the parliamentary Portfolio Committee. *Develop and review performance reporting templates to ensure legislative compliance. *Provide business plan performance data for the quarterly and annual report.
Stakeholder Management *Collaborate with internal and external stakeholders to ensure that SAHPRA’s performance information is provided timeously and within the guidelines of National Treasury, Department of Planning, Monitoring and Evaluation, National Department Health and the Board. *Support and serve on internal and external committees, task forces, and working groups related to business performance monitoring and evaluation within the public sector. * Collaborate with Project teams to collate project performance reports in accordance with Grant/Donor reporting requirements.
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: Email: Matshepo.mokotong@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 27 February 2023 at 16H00.
MANAGER: Business Planning and Performance Monitoring
Salary: SMS Level 13 (R1 073 187)
Ref No.: SAHPRA 005/2023
CENTRE: Pretoria
REQUIREMENTS: B. Comm or Business Administration Degree or equivalent as a minimum. A Post graduate qualification will be advantageous. Business Analyst certification or Project Management certification will be advantageous.
Experience: Minimum of 3 years’ experience in business performance monitoring and evaluation at a managerial level.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: *Analytical skills: The ability to analyze situations and to arrive at the best possible solution. *Facilitation skills: The ability to facilitate events and interventions to achieve the best possible results. *Interpersonal: The ability to interact with people at all levels in the organization. *Problem solving: The ability to apply the principles of problem-solving techniques to identify and resolve a problem in the best interest of all stakeholders. *Negotiation skills: The ability to negotiate with role players and arrive at a win-win situation in the best interest of the organisation and the negotiating party. *Time Management skills: The ability to manage time effectively and efficiently in accordance with work priorities to ensure qualitative outcomes. *Communication skills: The ability to communicate effectively and efficiently at all levels in the organization. *Presentation skills: The ability to conduct presentations at all levels in the organisation with and without presentation aids. *Reporting skills: The ability to accurately give an account of information pertaining to the performance of outputs. *Management: The ability to plan, organize, lead and control in the work environment to achieve the business objectives. *Organizing: To apply or impose efficient working methods in order to work effectively or make somebody else work effectively.
DUTIES: Strategic Business Planning *Development of the Strategic Plan document and Annual Performance Plan document for the entity. *Conduct workshops to obtain inputs to the Operational Plan documents with all business units. *Supports the development of business unit’s operational plan documents to ensure objectives are realistic and measurable. *Ensure alignment of business units' deliverables with SAHPRA’s strategic goals.
Performance Monitoring *Design and implement/improve performance monitoring guidelines, templates and processes. *Gather and evaluate performance information monthly, quarterly and annually from the business units and provide analytics insights to the relevant Executives through management dashboards & reports. Specifically focus on deviations and corrective action plans to course-correct to achieve performance targets*Coordinate monitoring and evaluation of performance against the business unit’s operational plans. *Ensure accurate response to audit queries on business performance before they become findings. *Identify, manage and coordinate the implementation of knowledge systems, tools and initiatives to improve business monitoring and evaluation. *Collection and verification of performance evidence as necessary.
Business Performance Reporting *Compile business performance reports as guided by legislation (National Department of Health and Department of Planning, Monitoring and Evaluation). * Collate information from business units, synthesise and ensure the completion of quarterly and annual reporting. *Prepare and update the annual performance report for presenting to the parliamentary Portfolio Committee. *Develop and review performance reporting templates to ensure legislative compliance. *Provide business plan performance data for the quarterly and annual report.
Stakeholder Management *Collaborate with internal and external stakeholders to ensure that SAHPRA’s performance information is provided timeously and within the guidelines of National Treasury, Department of Planning, Monitoring and Evaluation, National Department Health and the Board. *Support and serve on internal and external committees, task forces, and working groups related to business performance monitoring and evaluation within the public sector. * Collaborate with Project teams to collate project performance reports in accordance with Grant/Donor reporting requirements.
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: Email: Matshepo.mokotong@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 27 February 2023 at 16H00.
MEDICINE REGISTRATION OFFICER: PRE-REGISTRATION X 3
(PHARMACEUTICAL EVALUATION MANAGEMENT)
Salary: R692 830.00 – R837 326.00 p/a (All-inclusive)
Ref No.: SAHPRA 007/2023
CENTRE: Pretoria
REQUIREMENTS: ● 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) - (Proof of registration [Current Designation Letter] must accompany the application) OR 4-year Science Degree in a health science related field from a recognised university or tertiary institution.
Experience: ● 2 years’ work experience within a pharmaceutical regulatory environment.
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. * Knowledge of technical aspects for evaluation of quality and efficacy of bioequivalence of medicines as outlined by: * Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. *Self-motivated and able to work independently. *Ability to manage a variety of cross-functional team members. *Decision making informed by technical expertise. Communication skills (written, verbal, negotiation, conflict management, presentation). *Assertiveness. * Ethical behaviour. * Customer service. *Planning and organising skills.
DUTIES: ● Evaluation of new applications and peer-reviewing of new applications: *Generate evaluation report (s) for each new applications (NCE and Generics) in compliance with required template and adopted regulatory/scientific standards and submit for peer review. * Following peer review process, amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. *Primary report (s) are initially generated by new or junior members of the team, with peer-reviews carried out by more senior or more experienced members of the team. *Prepare report (s) for the internal working groups and where necessary present at advisory committee for complex scientific matters. * Prepare query letter to the applicant. *Prepare a basis of approval or rejection. * Provide quality assurance of reports and facilitate resolutions on technical matters.
● Evaluate applicant responses for registration/approval of medicines: *Generate second (and subsequent) evaluation report (s) for each response application and submit for peer review in compliance with required template and adopted regulatory/scientific standards and submit for peer review. * Following peer review process, amend the report accordingly to generate a list of queries to the applicant, if necessary. * Peer review other evaluators response reports, according to the required template and adopted regulatory/scientific standards. *Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. *Prepare query letter to the applicant. *Prepare a basis of approval or rejection. *Provide quality assurance of reports and facilitate resolutions on technical matters.
● Technical screening for the quality and efficacy (bioequivalence) aspects of new applications for the registration of medicines. *Generate technical screening evaluation report (s) for each application and submit for peer review. *Following peer review process amend the technical screening report (s) accordingly to generate a list of queries to the applicant using the correct templates. *Peer-review technical screening report (s) done by other reviewers. *Prepare screening query / screening report (s) done by other reviewers. *Prepare screening/query/screening rejection letter to the applicant. *Provide quality assurance of reports and facilitate resolutions on technical matters.
● Develop and update guidelines, SOPs, and templates: * Review existing guidelines, SOPs and templates and update when necessary. *Provide training on guidelines, SOPs, and templates. *Create new guidelines, SOP’s, and templates where SOPs aren’t in place. *Provide regular work-plans and output to the unit manger (qualitative and quantities report). *Perform any other relate duty as requested by manager/senior manager.
● Form part of technical working groups or special projects and provide support to the unit as well as to the Advisory Committees: *Participate in special projects and registration group. *Lead and manage assessments peer review and discussion working group where relevant. *Compile discussion documents and reports. *Provide regular trainings to new MRO’s and external evaluators. *Take comprehensive notes of relevant discussions. * Prepare documents for SAHPRA management/RC meeting.
● Risk Management and Audit: *SOP’s and Guidelines must be adhered to. *Create and maintain data bases. *Use the most current templates and guidelines. *Provide and attend the relevant training as may be necessary. *Align with QMS requirements. *Align with ICH, WHO, IPRP and international standards.
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: 23 February 2023 at 16H00.
MEDICINE REGISTRATION OFFICER: PRE-REGISTRATION X 3
(PHARMACEUTICAL EVALUATION MANAGEMENT)
Salary: R692 830.00 – R837 326.00 p/a (All-inclusive)
Ref No.: SAHPRA 007/2023
CENTRE: Pretoria
REQUIREMENTS: ● 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) - (Proof of registration [Current Designation Letter] must accompany the application) OR 4-year Science Degree in a health science related field from a recognised university or tertiary institution.
Experience: ● 2 years’ work experience within a pharmaceutical regulatory environment.
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. * Knowledge of technical aspects for evaluation of quality and efficacy of bioequivalence of medicines as outlined by: * Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. *Self-motivated and able to work independently. *Ability to manage a variety of cross-functional team members. *Decision making informed by technical expertise. Communication skills (written, verbal, negotiation, conflict management, presentation). *Assertiveness. * Ethical behaviour. * Customer service. *Planning and organising skills.
DUTIES: ● Evaluation of new applications and peer-reviewing of new applications: *Generate evaluation report (s) for each new applications (NCE and Generics) in compliance with required template and adopted regulatory/scientific standards and submit for peer review. * Following peer review process, amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. *Primary report (s) are initially generated by new or junior members of the team, with peer-reviews carried out by more senior or more experienced members of the team. *Prepare report (s) for the internal working groups and where necessary present at advisory committee for complex scientific matters. * Prepare query letter to the applicant. *Prepare a basis of approval or rejection. * Provide quality assurance of reports and facilitate resolutions on technical matters.
● Evaluate applicant responses for registration/approval of medicines: *Generate second (and subsequent) evaluation report (s) for each response application and submit for peer review in compliance with required template and adopted regulatory/scientific standards and submit for peer review. * Following peer review process, amend the report accordingly to generate a list of queries to the applicant, if necessary. * Peer review other evaluators response reports, according to the required template and adopted regulatory/scientific standards. *Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. *Prepare query letter to the applicant. *Prepare a basis of approval or rejection. *Provide quality assurance of reports and facilitate resolutions on technical matters.
● Technical screening for the quality and efficacy (bioequivalence) aspects of new applications for the registration of medicines. *Generate technical screening evaluation report (s) for each application and submit for peer review. *Following peer review process amend the technical screening report (s) accordingly to generate a list of queries to the applicant using the correct templates. *Peer-review technical screening report (s) done by other reviewers. *Prepare screening query / screening report (s) done by other reviewers. *Prepare screening/query/screening rejection letter to the applicant. *Provide quality assurance of reports and facilitate resolutions on technical matters.
● Develop and update guidelines, SOPs, and templates: * Review existing guidelines, SOPs and templates and update when necessary. *Provide training on guidelines, SOPs, and templates. *Create new guidelines, SOP’s, and templates where SOPs aren’t in place. *Provide regular work-plans and output to the unit manger (qualitative and quantities report). *Perform any other relate duty as requested by manager/senior manager.
● Form part of technical working groups or special projects and provide support to the unit as well as to the Advisory Committees: *Participate in special projects and registration group. *Lead and manage assessments peer review and discussion working group where relevant. *Compile discussion documents and reports. *Provide regular trainings to new MRO’s and external evaluators. *Take comprehensive notes of relevant discussions. * Prepare documents for SAHPRA management/RC meeting.
● Risk Management and Audit: *SOP’s and Guidelines must be adhered to. *Create and maintain data bases. *Use the most current templates and guidelines. *Provide and attend the relevant training as may be necessary. *Align with QMS requirements. *Align with ICH, WHO, IPRP and international standards.
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: 23 February 2023 at 16H00.
PORTFOLIO COORDINATOR
Health Products Authorisations
Ref No.: SAHPRA 009/2023
SALARY LEVEL: 11 (R788 910, in leu of 37% benefits included)
CENTRE: PRETORIA
REQUIREMENTS: Relevant Bachelor’s Degree in Pharmacy or Natural Sciences NQF Level 7 plus a certificate in Project Management.
Experience: 3 years of relevant experience in a medicines regulatory environment.
COMPETENCIES / ATTRIBUTES REQUIRED: * Sound knowledge of relevant legislation, requirements and procedures pertaining to medicine applications. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. *Strong administrative, planning and organizational skills. *Proficient in MS Office. *Willingness to work extended hours as when required. *Good, effective communication skills (verbal, written, conflict management and resolution). *Ability to work well under high pressure. *Ability to work unsupervised and within a team environment. *Ability to meet tight deadlines and manage multiple priorities. *Ethical behaviour and adherence to the SAHPRA Code of Conduct.
DUTIES:
• Receiving and recording of applications received
• Manage the l screening process of applications
• Manage the allocation of applications for review
• Manage the process of priority review requests
• Manage the processing of Evaluator claims
• Develop standard operating procedures (SOPs) and manage staff
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: Matshepo.mokotong@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 23 February 2023 at 16H00.