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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.
ASSISTANT MANAGER: RADIATION CONTROL INSPECTORATE
SALARY: R 832 300.00 – R883 379.00 per annum. (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 005/2024
CENTRE: PRETORIA
REQUIREMENTS: • Matric certificate and Degree in Diagnostic Radiography or Nuclear Medicine or Radiation Oncology or related equivalent qualification at NQF level 8 as recognised by SAQA. A relevant post graduate qualification will be an added advantage. Registration with HPCSA. • Working knowledge of Computer skills (MS Office). • A valid Driver’s License. • Minimum experience of 10 years working experience as Radiographer in Radiation Oncology and/or Nuclear Medicine and/or Diagnostic Radiology, of which three (3) should be at managerial level. Working knowledge of or experience with relevant national legislation and international standards.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:• * Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures, and work instructions. * Self-motivated and able to work independently. * Ability to manage a variety of cross-functional team members. * Competent in problem solving, research skills and team building. * Attention to detail, * Information evaluation * Decision making * Objectivity * Resilience * Communication skills (verbal, written, negotiation, conflict management, presentation). * Interpersonal skills * Assertiveness * Ethical behaviour * Customer service *Planning and organising skills *Team management.
DUTIES:
Operations and processes of the sub-unit: Plan and perform inspections in accordance with the Hazardous Substances Act, related regulations and code of practice. Ensure enforcement of related regulations to licence holders who are non-compliant. Prepare formal reports of your finding/s during inspections. Attend to queries related to radiation control inspectorate sub-unit. Assist in ensuring accuracy and improvement of the database of the sub-unit. Performing inspections: Participate in inspection activities involving high risk electronic generators of ionizing radiation such as linear accelerators, cyclotrons, industrial radiography etc. Perform radiation safety measurements to ensure regulatory compliance of licence holders in accordance with national regulations and codes of practice. Verification of quality control tests from licence holders’ equipment’s as prescribed by national standards.
Management of incident reporting procedures: Receive and investigate incidents and accidents as reported by licence holders. Receive and investigate occupational radiation overexposures from licence holders as supplied by approved dosimetry laboratories. Provide analyses and reports in accordance with standard procedures and prescribed format. Ensure international standards are maintained in managing the radiation protection processes. Management of risks and audit queries: Developing and implementing of guidelines, code of conducts and standard operating procedures. Participate in offering advises and training/workshop to industry stakeholders related to the subunit. Participate in national and/or international collaboration related to regulatory function under the guidance of Deputy Manager and Senior Management. Receive and respond to various queries received by the subunit in accordance with query management standard procedure.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, 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.
- 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
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.
MEDICINES REGISTRATION OFFICER - PHARMACOVIGILANCE X4
(FIXED TERM CONTRACT POSITION: 12 MONTHS)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service
Ref No.: SAHPRA 006/2024
CENTRE: PRETORIA
REQUIREMENTS: • Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA. • A postgraduate qualification in relevant Pharmacy field will be an added advantage. Proficient in MS Office. *A valid Driver’s License.
EXPERIENCE: (Grade 1 – 4-year Bachelor of Pharmacy Degree at NQF level 8 as recognised by SAQA plus a minimum of five (5) years of experience in regulatory). (Grade 2 - 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years’ experience in regulatory. • Knowledge and application of the Medicines and Related Substances Act (Act 101 of 1965) as amended and its Regulations. • Knowledge of quality, safety, and efficacy aspects of medicines. • Knowledge of medicines registration with respect to safety and efficacy of medicines. • Experience in drafting stakeholder communications and articles.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:• Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965 as amended.• Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data.• Good, effective communication skills (verbal, written, conflict management and resolution).• Delivery of service objectives with professional excellence and efficiency.• Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision.• Ability to work unsupervised for long periods of time.• Ability to work within a team environment.• Good planning and organisational skills.• Promoting a more proactive, service oriented and performance-based management culture.• Ability to meet tight deadlines and manage multiple, often competing priorities.• Proficient knowledge of relevant platforms (VigiBase, VigiFlow, Vigilance Hub, etc.).• Ethical behaviour and adherence to the SAHPRA Code of Conduct. An understanding of the Adverse Drug Reaction (ADR)/Adverse Drug Event (ADE) reporting processes, training capabilities and case investigations.
DUTIES: • Individual case safety reports management: * Processing of adverse drug events reports. * Clinical case assessment of adverse drug reaction reports and feedback provision to reporters. * Signal detection and management. * Reporter follow-up and system update. • Benefit-Risk assessment: * Investigate and review medicines safety concerns and prepare review reports for peer review and/or Pharmacovigilance Technical Advisory Committee discussions. * Peer review technical reports. * Technical support to the Pharmacovigilance Technical Advisory Committee. * Publication of safety regulatory decisions made by the Authority. • Medicine Safety Communication: * Draft, finalise and communicate safety communication documents (DHCPL, Newsletter, Articles, MSAs, Media Queries, Press release) as per the guiding principles. • PV stakeholder management: * Identify key stakeholder for engagements. * Arrange/participate in the stakeholder engagements. * Record/Minute the discussions and action plans. * Ensure implementation and follow-up of resolutions. • Promote PV awareness and outreach: * Develop a quarterly PV awareness and outreach plan. * Develop/update PV training materials. * Train healthcare professionals and the public on pharmacovigilance. * Coordinate medicine safety webinars. • Development and maintenance of guiding principles (SOPs, guidelines, policies, etc.) to ensure consistency, efficiency and alignment of PV processes: * Identify and implement new approaches to improve and maintain high levels of operational efficiency and effectiveness. * Update policy documents in line with international standards to improve and maintain high levels of operational efficiency and effectiveness. * Development and maintenance of guiding principles (SOPs, guidelines, policies, etc.) to ensure consistency, efficiency and alignment of PV processes.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
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.
MEDICINES REGISTRATION OFFICER - PHARMACOVIGILANCE X4
(FIXED TERM CONTRACT POSITION: 12 MONTHS)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service
Ref No.: SAHPRA 006/2024
CENTRE: PRETORIA
REQUIREMENTS: • Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA. • A postgraduate qualification in relevant Pharmacy field will be an added advantage. Proficient in MS Office. *A valid Driver’s License.
EXPERIENCE: (Grade 1 – 4-year Bachelor of Pharmacy Degree at NQF level 8 as recognised by SAQA plus a minimum of five (5) years of experience in regulatory). (Grade 2 - 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of three (3) years’ experience in regulatory. • Knowledge and application of the Medicines and Related Substances Act (Act 101 of 1965) as amended and its Regulations. • Knowledge of quality, safety, and efficacy aspects of medicines. • Knowledge of medicines registration with respect to safety and efficacy of medicines. • Experience in drafting stakeholder communications and articles.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:• Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965 as amended.• Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data.• Good, effective communication skills (verbal, written, conflict management and resolution).• Delivery of service objectives with professional excellence and efficiency.• Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision.• Ability to work unsupervised for long periods of time.• Ability to work within a team environment.• Good planning and organisational skills.• Promoting a more proactive, service oriented and performance-based management culture.• Ability to meet tight deadlines and manage multiple, often competing priorities.• Proficient knowledge of relevant platforms (VigiBase, VigiFlow, Vigilance Hub, etc.).• Ethical behaviour and adherence to the SAHPRA Code of Conduct. An understanding of the Adverse Drug Reaction (ADR)/Adverse Drug Event (ADE) reporting processes, training capabilities and case investigations.
DUTIES: • Individual case safety reports management: * Processing of adverse drug events reports. * Clinical case assessment of adverse drug reaction reports and feedback provision to reporters. * Signal detection and management. * Reporter follow-up and system update. • Benefit-Risk assessment: * Investigate and review medicines safety concerns and prepare review reports for peer review and/or Pharmacovigilance Technical Advisory Committee discussions. * Peer review technical reports. * Technical support to the Pharmacovigilance Technical Advisory Committee. * Publication of safety regulatory decisions made by the Authority. • Medicine Safety Communication: * Draft, finalise and communicate safety communication documents (DHCPL, Newsletter, Articles, MSAs, Media Queries, Press release) as per the guiding principles. • PV stakeholder management: * Identify key stakeholder for engagements. * Arrange/participate in the stakeholder engagements. * Record/Minute the discussions and action plans. * Ensure implementation and follow-up of resolutions. • Promote PV awareness and outreach: * Develop a quarterly PV awareness and outreach plan. * Develop/update PV training materials. * Train healthcare professionals and the public on pharmacovigilance. * Coordinate medicine safety webinars. • Development and maintenance of guiding principles (SOPs, guidelines, policies, etc.) to ensure consistency, efficiency and alignment of PV processes: * Identify and implement new approaches to improve and maintain high levels of operational efficiency and effectiveness. * Update policy documents in line with international standards to improve and maintain high levels of operational efficiency and effectiveness. * Development and maintenance of guiding principles (SOPs, guidelines, policies, etc.) to ensure consistency, efficiency and alignment of PV processes.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, 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.
- 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
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.
VIGILANCE LIAISON OFFICER X4
(FIXED TERM CONTRACT POSITION: 12 MONTHS)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service
Ref No.: SAHPRA 007/2024
CENTRE: KWAZULU-NATAL, NORTH-WEST, FREE STATE & EASTERN CAPE PROVINCES
REQUIREMENTS: • Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA. • A postgraduate qualification in relevant Pharmacy field will be an added advantage. Proficient in MS Office. *A valid Driver’s License.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:• Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965 as amended.• Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data.• Good, effective communication skills (verbal, written, conflict management and resolution).• Delivery of service objectives with professional excellence and efficiency.• Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision.• Ability to work unsupervised for long periods of time.• Ability to work within a team environment.• Good planning and organisational skills.• Promoting a more proactive, service oriented and performance-based management culture.• Ability to meet tight deadlines and manage multiple, often competing priorities.• Proficient knowledge of relevant platforms (VigiBase, VigiFlow, Vigilance Hub, etc.).• Ethical behaviour and adherence to the SAHPRA Code of Conduct. An understanding of the Adverse Drug Reaction (ADR)/Adverse Drug Event (ADE) reporting processes, training capabilities and case investigations.
DUTIES:
1. Improve provincial coordination of vaccine and therapeutics safety reporting and case management.
1.1 Formalise linkages with PDOH to facilitate SAHPRA decentralized pharmacovigilance support activities:
1.2 Implement procedures and strengthen coordination with provincial and district level DOH staff to improve AEFI reporting and case management activities:
2. Strengthen provincial safety committees and linkages to SAHPRA.
2.1 Work with the PDOH counterparts to implement/strengthen provincial safety committees:
2.2 Review and streamline procedures for safety committees and strengthen capacity for preliminary safety assessments for vaccines and therapeutics:
2.3 Support the work of the PISEC:
3. Strengthen pharmacovigilance knowledge for healthcare professionals within the province.
3.1 Implement targeted pharmacovigilance training for managers and healthcare personnel in both public and private sectors:
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
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.
VIGILANCE LIAISON OFFICER X4
(FIXED TERM CONTRACT POSITION: 12 MONTHS)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service
Ref No.: SAHPRA 007/2024
CENTRE: KWAZULU-NATAL, NORTH-WEST, FREE STATE & EASTERN CAPE PROVINCES
REQUIREMENTS: • Matric certificate and appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA. • A postgraduate qualification in relevant Pharmacy field will be an added advantage. Proficient in MS Office. *A valid Driver’s License.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:• Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965 as amended.• Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data.• Good, effective communication skills (verbal, written, conflict management and resolution).• Delivery of service objectives with professional excellence and efficiency.• Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision.• Ability to work unsupervised for long periods of time.• Ability to work within a team environment.• Good planning and organisational skills.• Promoting a more proactive, service oriented and performance-based management culture.• Ability to meet tight deadlines and manage multiple, often competing priorities.• Proficient knowledge of relevant platforms (VigiBase, VigiFlow, Vigilance Hub, etc.).• Ethical behaviour and adherence to the SAHPRA Code of Conduct. An understanding of the Adverse Drug Reaction (ADR)/Adverse Drug Event (ADE) reporting processes, training capabilities and case investigations.
DUTIES:
1. Improve provincial coordination of vaccine and therapeutics safety reporting and case management.
1.1 Formalise linkages with PDOH to facilitate SAHPRA decentralized pharmacovigilance support activities:
- Engage with the PDoH to ensure harmonisation and coordination of PV activities.
- Ensure formal linkages to support the reporting and accountabilities.
1.2 Implement procedures and strengthen coordination with provincial and district level DOH staff to improve AEFI reporting and case management activities:
- Develop/update reporting procedures for both AEFIs and therapeutics ADRs and co-ordinate finalisation.
- Socialise reporting procedures within the province for proper implementation.
- Monitor compliance with the new processes and continue with socialisation.
2. Strengthen provincial safety committees and linkages to SAHPRA.
2.1 Work with the PDOH counterparts to implement/strengthen provincial safety committees:
- Engage with the principles (HOPS, PV Leads, HOD) regarding the need for the development of safety committee.
- Establish/strengthen Pharmaceutical & Therapeutics Committees at institutional, district and provincial levels.
- Establish the formation of the Provincial Immunisation Safety Expert Committee.
2.2 Review and streamline procedures for safety committees and strengthen capacity for preliminary safety assessments for vaccines and therapeutics:
- Develop 2024 PISEC meeting schedule and communicate to relevant structures.
- Develop/review and finalise meeting conduct procedures e.g., Terms of reference, etc.
- Arrange training for PISEC members.
2.3 Support the work of the PISEC:
- Track all AEFI investigations and report on the progress.
- Coordinate and participate in AEFI/AE case investigations.
- Coordinate case allocation for assessment by PISEC members.
- Coordinate all PISEC meetings.
- Communicate all PISEC pre-liminary findings to NISEC for further assessment.
- Ensure case closure and provision of feedback to the vaccinees and family members.
3. Strengthen pharmacovigilance knowledge for healthcare professionals within the province.
3.1 Implement targeted pharmacovigilance training for managers and healthcare personnel in both public and private sectors:
- Develop 2024 training plan.
- Coordinate and implement trainings for healthcare professionals and managers in both private and private sectors as per the plan.
- Coordinate and train all the train-the-trainers planned for the province.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, 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.
- 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
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 OFFICER: MEDICAL DEVICES CLINICAL ASSESSOR (CLINICAL TRIALS & EVALUATION)
(FIXED TERM CONTRACT POSITION: 12 MONTHS)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 008/2024
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year degree in Natural / Medical Sciences/ Clinical Engineering/ Pharmacy at NQF level 8 as recognised by SAQA. A relevant post graduate qualification will be an added advantage. Registration with the relevant professional body.
EXPERIENCE: Grade 1 – an appropriate 4-year degree in Natural / Medical Sciences/ Clinical Engineering / Pharmacy and a minimum of five (5) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or clinical trials of medical devices, assessment of quality, safety, performance of medical devices and development and maintenance of standard operating procedures and technical guidelines.
Grade 2 - 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of five (5) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or clinical of medical devices, assessment of quality, safety, performance of medical devices and development and maintenance of standard operating procedures and technical guidelines or Natural / Medical Sciences/ Clinical Engineering and registration with the relevant professional body and a minimum of ten (10) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or clinical trials of medical devices, assessment of quality, safety, performance of medical devices and development and maintenance of standard operating procedures and technical guidelines.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. Preparation of financial reports. Performance measurement skills. Self-motivated and able to work independently. Ability to work with a variety cross-functional team members. Competent in problem solving. Information evaluation. Decision making. Objectivity. Resilience. Communication skills (verbal, written, negotiation, conflict management, presentation). Interpersonal skills. Assertiveness. Ethical behaviour. Customer service. Planning and organising skills. Teamwork. Scientific report writing.
DUTIES:
Develop and maintain guidelines and standard operating procedures for medical device and IVD clinical trials. Technical screening of new clinical trial applications and allocation of clinical trials to the evaluators. Review protocol amendments and additional investigators and site/s. Attend to queries addressed concerning Clinical Trials Unit. Evaluate and manage applications for clinical trials of medical devices and IVDs and maintain relevant databases.
To evaluate applications for clinical trials for medical devices being conducted in South Africa or Outside South Africa, if necessary. Prepare reports for SAHPRA and relevant advisory committees.
Liaise with international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Interview members from industry to discuss SAHPRA Board resolutions, requirements of the Act and medical device and IVD clinical trial issues. Investigate and attend to industry / applicant’s queries. Perform other related functions that may arise from time to time. Capture and maintain data relating to measuring and monitoring of performance metrics and peer reviewed reports, and record statistics generated, including the units quarterly report and monthly financial reports. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports).
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
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 OFFICER: MEDICAL DEVICES CLINICAL ASSESSOR (CLINICAL TRIALS & EVALUATION)
(FIXED TERM CONTRACT POSITION: 12 MONTHS)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 008/2024
CENTRE: Pretoria
Requirements: Matric certificate and appropriate 4-year degree in Natural / Medical Sciences/ Clinical Engineering/ Pharmacy at NQF level 8 as recognised by SAQA. A relevant post graduate qualification will be an added advantage. Registration with the relevant professional body.
EXPERIENCE: Grade 1 – an appropriate 4-year degree in Natural / Medical Sciences/ Clinical Engineering / Pharmacy and a minimum of five (5) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or clinical trials of medical devices, assessment of quality, safety, performance of medical devices and development and maintenance of standard operating procedures and technical guidelines.
Grade 2 - 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of five (5) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or clinical of medical devices, assessment of quality, safety, performance of medical devices and development and maintenance of standard operating procedures and technical guidelines or Natural / Medical Sciences/ Clinical Engineering and registration with the relevant professional body and a minimum of ten (10) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or clinical trials of medical devices, assessment of quality, safety, performance of medical devices and development and maintenance of standard operating procedures and technical guidelines.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. Preparation of financial reports. Performance measurement skills. Self-motivated and able to work independently. Ability to work with a variety cross-functional team members. Competent in problem solving. Information evaluation. Decision making. Objectivity. Resilience. Communication skills (verbal, written, negotiation, conflict management, presentation). Interpersonal skills. Assertiveness. Ethical behaviour. Customer service. Planning and organising skills. Teamwork. Scientific report writing.
DUTIES:
Develop and maintain guidelines and standard operating procedures for medical device and IVD clinical trials. Technical screening of new clinical trial applications and allocation of clinical trials to the evaluators. Review protocol amendments and additional investigators and site/s. Attend to queries addressed concerning Clinical Trials Unit. Evaluate and manage applications for clinical trials of medical devices and IVDs and maintain relevant databases.
To evaluate applications for clinical trials for medical devices being conducted in South Africa or Outside South Africa, if necessary. Prepare reports for SAHPRA and relevant advisory committees.
Liaise with international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Interview members from industry to discuss SAHPRA Board resolutions, requirements of the Act and medical device and IVD clinical trial issues. Investigate and attend to industry / applicant’s queries. Perform other related functions that may arise from time to time. Capture and maintain data relating to measuring and monitoring of performance metrics and peer reviewed reports, and record statistics generated, including the units quarterly report and monthly financial reports. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports).
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, 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.
- 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
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 OFFICER: MEDICAL DEVICES COMPLIANCE
(FIXED TERM CONTRACT POSITION: 12 MONTHS)
SALARY: R 657 376.00 – R834 199.00 per annum (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 009/2024
CENTRE: PRETORIA
REQUIREMENTS: Matric certificate and a 4-year degree in Pharmacy Medical Sciences /Clinical Engineering at an equivalent NQF level 8 as recognised by SAQA. Registration with the relevant professional body. Postgraduate qualification will be an added advantage. Valid Driver’s License.
EXPERIENCE: Grade 1 – 4-year degree in Pharmacy or Honours Degree in Medical Sciences /Clinical Engineering at NQF level 8 as recognised by SAQA. Registration with the relevant professional body. Minimum three (3) years’ experience of which two (2) years’ must be regulatory in Medical Devices and IVDs. Knowledge and/or understanding of Medical Devices Regulatory Compliance, QMS and Medical Devices Licencing legislative requirements.
Grade 2 – 4-year degree Pharmacy in Medical Sciences /Clinical Engineering NQF level 8 as recognised by SAQA. Registration with the relevant body. Minimum eight (8) years’ experience of which five (5) years’ must be regulatory in Medical Devices and IVDs. Working knowledge and/or understanding of Medical Devices Regulatory Compliance, QMS and Medical Devices Licencing requirements. Postgraduate qualification will be an added advantage.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: Comprehensive knowledge and understanding of relevant legislation, Medicine and Related Substances Act 101 of 1965, Regulations relating to Medical Devices and IVDs. Computer literacy and MS windows computer skills, Excel and database applications. Good report writing and presentation skills. Good planning and organization skills. Good verbal and written communication skills. Self-motivated and able to work independently. Ability to manage a variety of cross-functional team members. Pay attention to detail and information evaluation. Ethical behaviour and adherence to the SAHPRA Code of Conduct. At SAHPRA we adhere to our core values: Ubuntu, Responsiveness, Integrity, Transparency, Efficiency, Excellence.
DUTIES:
Evaluate and manage licence applications for medical device establishments and maintain relevant databases. Prepare reports for SAHPRA and relevant advisory committees, for compliance related matters. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Liaise with international regulatory authorities. Monitor compliance with the provision of the Medicines Act and other related Health Acts regarding medical devices and IVDs. Develop and review guidelines and standard operating procedures for Medical Devices Licencing. Proactively audit processes, practices, guidelines and standard operating procedures for Medical Devices Licencing. Acts as contact person and liaison between Regulatory Compliance, QMS and Medical Devices Licencing.
Facilitate training of Medical Devices Licencing staff on matters related to any legal changes and updates to compliance guidelines. Investigate complaints from Regulatory compliance for any transgressions against the Medicines Act and other related Health Acts regarding medical devices and IVDs. Communicate with the members from industry regarding the SAHPRA Board resolutions, legislative requirements for medical device and IVDs. Investigate and attend to industry / applicants’ queries. Capture and maintain data relating to measuring and monitoring of performance metrics and peer reviewed reports, and record statistics generated. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports). Perform other related functions that may arise from time to time.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
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 OFFICER: MEDICAL DEVICES COMPLIANCE
(FIXED TERM CONTRACT POSITION: 12 MONTHS)
SALARY: R 657 376.00 – R834 199.00 per annum (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 009/2024
CENTRE: PRETORIA
REQUIREMENTS: Matric certificate and a 4-year degree in Pharmacy Medical Sciences /Clinical Engineering at an equivalent NQF level 8 as recognised by SAQA. Registration with the relevant professional body. Postgraduate qualification will be an added advantage. Valid Driver’s License.
EXPERIENCE: Grade 1 – 4-year degree in Pharmacy or Honours Degree in Medical Sciences /Clinical Engineering at NQF level 8 as recognised by SAQA. Registration with the relevant professional body. Minimum three (3) years’ experience of which two (2) years’ must be regulatory in Medical Devices and IVDs. Knowledge and/or understanding of Medical Devices Regulatory Compliance, QMS and Medical Devices Licencing legislative requirements.
Grade 2 – 4-year degree Pharmacy in Medical Sciences /Clinical Engineering NQF level 8 as recognised by SAQA. Registration with the relevant body. Minimum eight (8) years’ experience of which five (5) years’ must be regulatory in Medical Devices and IVDs. Working knowledge and/or understanding of Medical Devices Regulatory Compliance, QMS and Medical Devices Licencing requirements. Postgraduate qualification will be an added advantage.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: Comprehensive knowledge and understanding of relevant legislation, Medicine and Related Substances Act 101 of 1965, Regulations relating to Medical Devices and IVDs. Computer literacy and MS windows computer skills, Excel and database applications. Good report writing and presentation skills. Good planning and organization skills. Good verbal and written communication skills. Self-motivated and able to work independently. Ability to manage a variety of cross-functional team members. Pay attention to detail and information evaluation. Ethical behaviour and adherence to the SAHPRA Code of Conduct. At SAHPRA we adhere to our core values: Ubuntu, Responsiveness, Integrity, Transparency, Efficiency, Excellence.
DUTIES:
Evaluate and manage licence applications for medical device establishments and maintain relevant databases. Prepare reports for SAHPRA and relevant advisory committees, for compliance related matters. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Liaise with international regulatory authorities. Monitor compliance with the provision of the Medicines Act and other related Health Acts regarding medical devices and IVDs. Develop and review guidelines and standard operating procedures for Medical Devices Licencing. Proactively audit processes, practices, guidelines and standard operating procedures for Medical Devices Licencing. Acts as contact person and liaison between Regulatory Compliance, QMS and Medical Devices Licencing.
Facilitate training of Medical Devices Licencing staff on matters related to any legal changes and updates to compliance guidelines. Investigate complaints from Regulatory compliance for any transgressions against the Medicines Act and other related Health Acts regarding medical devices and IVDs. Communicate with the members from industry regarding the SAHPRA Board resolutions, legislative requirements for medical device and IVDs. Investigate and attend to industry / applicants’ queries. Capture and maintain data relating to measuring and monitoring of performance metrics and peer reviewed reports, and record statistics generated. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports). Perform other related functions that may arise from time to time.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, 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.
- 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
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 OFFICER: MEDICAL DEVICES REGISTRATION X3
(FIXED TERM CONTRACT POSITION: 12 MONTHS)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 010/2024
CENTRE: Pretoria
REQUIREMENTS: Matric certificate and appropriate 4-year degree in Natural / Medical Sciences/ Clinical Engineering/ Pharmacy at NQF level 8 as recognised by SAQA. A relevant post graduate qualification will be an added advantage. Registration with the relevant professional body.
EXPERIENCE: Grade 1 – an appropriate 4-year degree in Pharmacy a minimum of five (5) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or registration of medical devices, assessment of quality, safety, performance of medical devices and development and maintenance of standard operating procedures and technical guidelines.
Grade 2 - 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of five (5) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or registration of medical devices, assessment of quality, safety, performance of medical devices and development and maintenance of standard operating procedures and technical guidelines or Natural / Medical Sciences/ Clinical Engineering and registration with the relevant professional body and a minimum of ten (10) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or clinical trials of medical devices and development and maintenance of standard operating procedures and technical guidelines.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. Preparation of financial reports. Performance measurement skills. Self-motivated and able to work independently. Ability to work with a variety cross-functional team members. Competent in problem solving. Information evaluation. Decision making. Objectivity. Resilience. Communication skills (verbal, written, negotiation, conflict management, presentation). Interpersonal skills. Assertiveness. Ethical behaviour. Customer service. Planning and organising skills. Teamwork. Scientific report writing.
DUTIES: Develop and maintain guidelines and standard operating procedures for medical device and IVD registration. Screen, evaluate and manage applications for registration of medical devices and IVDs and maintain relevant databases. Prepare reports for SAHPRA and relevant advisory committees. Prepare reports and participate during medical device product registration meetings. Organize workshops and participate in any other relevant stakeholder engagement. Liaise with international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Liaise and monitor external evaluators work progress and assessment. Interview members from industry to discuss SAHPRA Board resolutions, requirements of the Act and medical device and IVD quality issues. Investigate and attend to industry / applicant’s queries. Perform other related functions that may arise from time to time. Capture and maintain data relating to measuring and monitoring performance metrics and peer reviewed reports, and record statistics generated, including the units quarterly report and monthly financial reports. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports).
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable.
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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
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 OFFICER: MEDICAL DEVICES REGISTRATION X3
(FIXED TERM CONTRACT POSITION: 12 MONTHS)
SALARY: R 657 376.00 – R834 199.00 per annum. (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 010/2024
CENTRE: Pretoria
REQUIREMENTS: Matric certificate and appropriate 4-year degree in Natural / Medical Sciences/ Clinical Engineering/ Pharmacy at NQF level 8 as recognised by SAQA. A relevant post graduate qualification will be an added advantage. Registration with the relevant professional body.
EXPERIENCE: Grade 1 – an appropriate 4-year degree in Pharmacy a minimum of five (5) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or registration of medical devices, assessment of quality, safety, performance of medical devices and development and maintenance of standard operating procedures and technical guidelines.
Grade 2 - 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) and minimum of five (5) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or registration of medical devices, assessment of quality, safety, performance of medical devices and development and maintenance of standard operating procedures and technical guidelines or Natural / Medical Sciences/ Clinical Engineering and registration with the relevant professional body and a minimum of ten (10) years working experience within the regulatory environment of which three (3) years of must be relevant in training and regulation and / or clinical trials of medical devices and development and maintenance of standard operating procedures and technical guidelines.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. Preparation of financial reports. Performance measurement skills. Self-motivated and able to work independently. Ability to work with a variety cross-functional team members. Competent in problem solving. Information evaluation. Decision making. Objectivity. Resilience. Communication skills (verbal, written, negotiation, conflict management, presentation). Interpersonal skills. Assertiveness. Ethical behaviour. Customer service. Planning and organising skills. Teamwork. Scientific report writing.
DUTIES: Develop and maintain guidelines and standard operating procedures for medical device and IVD registration. Screen, evaluate and manage applications for registration of medical devices and IVDs and maintain relevant databases. Prepare reports for SAHPRA and relevant advisory committees. Prepare reports and participate during medical device product registration meetings. Organize workshops and participate in any other relevant stakeholder engagement. Liaise with international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Liaise and monitor external evaluators work progress and assessment. Interview members from industry to discuss SAHPRA Board resolutions, requirements of the Act and medical device and IVD quality issues. Investigate and attend to industry / applicant’s queries. Perform other related functions that may arise from time to time. Capture and maintain data relating to measuring and monitoring performance metrics and peer reviewed reports, and record statistics generated, including the units quarterly report and monthly financial reports. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports).
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, 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.
- 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
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 OFFICER: MEDICAL DEVICES VIGILANCE X2
(FIXED TERM CONTRACT POSITION: 12 MONTHS)
SALARY: R 657 376.00 – R834 199.00 per annum (TOTAL COST TO COMPANY) (Grade 1 – Grade 2) Market related salary will be determined by the years of experience obtained post qualification and community service.
Ref No.: SAHPRA 011/2024
CENTRE: PRETORIA
REQUIREMENTS: Matric certificate and a 4-year degree in Pharmacy Medical Sciences /Clinical Engineering at an equivalent NQF level 8 as recognised by SAQA. Registration with the relevant professional body. Postgraduate qualification will be an added advantage. Valid Driver’s License.
EXPERIENCE: Grade 1 – 4-year degree in Pharmacy or Honours Degree in Medical Sciences /Clinical Engineering at NQF level 8 as recognised by SAQA. Registration with the relevant professional body. Minimum three (3) years’ experience of which two (2) years’ must be regulatory in Medical Devices and IVDs. Knowledge and/or understanding of Medical Devices Licencing, Vigilance and Post Marketing Surveillance requirements.
Grade 2 – 4-year degree Pharmacy in Medical Sciences /Clinical Engineering NQF level 8 as recognised by SAQA. Registration with the relevant body. Minimum eight (8) years’ experience of which five (5) years’ must be regulatory in Medical Devices and IVDs. Working knowledge and/or understanding of Medical Devices Licencing, Vigilance and Post Marketing Surveillance requirements. Postgraduate qualification will be an added advantage.
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: Comprehensive knowledge and understanding of relevant legislation, Medicine and Related Substances Act 101 of 1965, Regulations relating to Medical Devices and IVDs. Computer literacy and MS windows computer skills, Excel and database applications. Good report writing and presentation skills. Good planning and organization skills. Good verbal and written communication skills. Self-motivated and able to work independently. Ability to manage a variety of cross-functional team members. Pay attention to detail and information evaluation. Ethical behaviour and adherence to the SAHPRA Code of Conduct. At SAHPRA we adhere to our core values: Ubuntu, Responsiveness, Integrity, Transparency, Efficiency, Excellence.
DUTIES: Perform risk-based evaluation of vigilance reports for medical devices and IVDs. Manage further handling of vigilance activities and maintain relevant databases. Develop and maintain guidelines and standard operating procedures for Medical Devices Licencing and Vigilance. Evaluate and manage licence applications for medical device establishments and maintain relevant databases. Prepare reports for SAHPRA and relevant advisory committees. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Liaise with international regulatory authorities. Communicate with the members from industry regarding the SAHPRA Board resolutions, legislative requirements for medical device and IVDs. Investigate and attend to industry / applicant’s queries. Capture and maintain data relating to measuring and monitoring of performance metrics and peer reviewed reports, and record statistics generated. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports). Perform other related functions that may arise from time to time.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, 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.
- 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is 01 March 2024 at 16H00.
PLEASE APPLY HERE
CALL FOR NOMINATIONS FOR MEMBERS TO SERVE ON THE CEO TECHNICAL ADVISORY COMMITTEES
The South African Health Products Regulatory Authority (SAHPRA) hereby invite nominations for candidates to serve as CEO Technical Advisory Committee members.
SAHPRA is a Schedule 3A Public Entity established in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) to oversee the regulation of medicines, medical devices, and in vitro diagnostics (IVDs) intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices and IVDs; and the conduct of clinical trials.
REQUIREMENTS
The Technical Advisory Committees (TACs) are established in terms of Section 3(9) of the Medicines Act, as amended to investigate, and report to the Authority on any matter within its scope in terms of the Act. The CEO TAC is a team of external technical experts with adequate experience to provide advice on various technical and regulatory matters. Nominations are required in the following disciplines:
• Six (6) members for the Radiation Control Committee
Relevant Qualifications: Appropriate qualification in Medical Physics, Radiography/Clinical engineering/clinical technology, MMED Nuclear Medicine/ Radiology/Oncology and Medical Physics.
Applicant must be in good standing with the regulatory board/ council with which he/ she is registered where applicable.
Exclusions:
he or she does not meet the minimum requirements.
TERM OF OFFICE
The term of office for Committee members is three (3) years effective from date of appointment by the CEO and may be appointed for a further term(s).
Registration with the statutory regulatory board/council relating to his/her profession where applicable is recommended.
No person shall be eligible for appointment as an Expert for the Technical advisory Committee, if: -
- he or she is conflicted in terms of SAHPRA Policy on Management of Conflict of Interest (GOV02);
- he or she is disqualified under the Relevant Act applicable to his or her profession from practising as such;
- he or she has been found guilty of improper or disgraceful conduct at an inquiry held under ambit of the relevant Act;
- he or she is a patient as defined in section 1 of the Mental Health Care Act, 2002 (Act No. 17 of 2002);
- he or she has been convicted of an offence in respect whereof he or she was sentenced to imprisonment without the option of a fine or in the case of fraud;
PROCEDURE
• Duly completed nomination application, a comprehensive CV, qualification/s and a motivation expressing area of expertise must be submitted online at https://apply.sahpra.org.za:6006
• Only documents in pdf must be uploaded.
• Further communication will be limited to nominated candidates with appropriate skill sets.
• Closing date for nominations is Friday, 01 March 2024 at 16h30. No late nominations will be accepted.
Enquiries: Ms Mukona Mphidi at mukona.mphidi@sahpra.org.za
PLEASE APPLY HERE