SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

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CHIEF RADIATION CONTROL OFFICER GR 1 (RADIATION CONTROL INSPECTORATE) 
(FIXED TERM CONTRACT POSITION: 24 MONTHS) 
Salary: As per DPSA OSD Framework 
Ref No.: SAHPRA 052/2022 
CENTRE: DURBAN 
 
REQUIREMENTS: * B Rad Degree in Diagnostic Radiography/Nuclear Medicine/Radiation Therapy or equivalent NQF Level 7 qualification. * Professional current registration with the HPCSA (Proof to be submitted with application). 
 
EXPERIENCE: * Minimum 1 year working experience as radiographer and involved in quality assurance activities. * Knowledge of, and experience with, relevant national legislation and international standards. 
 
COMPETENCIES/SKILLS: * Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures, and work instructions. * Communication skills (verbal, written, negotiation, conflict management, presentation). * Interpersonal skills. * Assertiveness. * Ethical behaviour. * Customer service. * Team management. * MS Office (Word, Excel, Power Point). * Good health: eyesight, hearing, mobility. * A valid driver’s licence. 
 
DUTIES: • Internal operational processes: * Ensures effectiveness of internal branch processes by verifying the integrity of information and the capability of applicants to comply with the Act, regulations, conditions, and codes of conduct. * Performing risk assessments and reporting accordingly. • Compliance: * Ensures the compliance of applicants and licensees in the catchment area of the allocated branch by performing planned and unplanned inspections. * Compliance assurance investigations, and audits. * Initiating or performing enforcement actions in collaboration with Assistant Manager, licensing staff and other subunits. • Accidents and Incidents: * Responds to radiation incidents/accidents by verifying compliance with regulatory requirements and Instituting / initiating enforcement actions in the event of non-compliance. • Management of risks and audit queries: * Investigate and respond to radiation incidents/accidents to verify compliance to regulatory requirements. * Provide training and guidance to personnel and external stake holders. * Completion of monthly log sheets, statistics, travel and subsistence claims, and submissions of final monthly inspection programmes. * Developing of standard operating procedures in collaboration with other units i.e. Licensing and Radionuclides. 
 
Please Note: Some Inspections will be carried out in remote areas. Officials will have to undertake long journeys which will require them to be absent from home. 
 
 
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: 26 August 2022 at 16H00.
 
 
 

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RADIATION SCIENTIST GR 1 X3 (RADIONUCLIDES) 
(FIXED TERM CONTRACT POSITIONS: 24 MONTHS) 
Salary: As per DPSA OSD Framework 
Ref No.: SAHPRA 051/2022 
CENTRE: Cape Town (2) and Pretoria (1) 
 
REQUIREMENTS: * B. Rad (Nuclear Medicine or Radiography). * Professional registration with the HPCSA (current registration to be submitted with application). 
 
Experience: * Minimum relevant experience of 1 year working as a radiation scientist or radiographer (Nuclear Medicine or Radiography). * Working experience in administration, data management and supervisory skills will be an added advantage. 
 
COMPETENCIES/SKILLS: * Strong administrative and organizational skills. * Willingness to work extended hours as and when required. * Ability to read, write and communicate fluently in English. * Decision-making ability. * Critical thinking and problem-solving skills. * Planning and coordination skills. * Attention to detail. * Ability to manage conflict. * Ability to work under pressure. * Deadline driven. * Innovative thinking. * Supervisory skills. * Team player and can work independently. * Interpersonal skills. * A valid driver’s licence. 
 
DUTIES: • Review and screening of applications: * Review and verify license applications for completeness, correctness, and compliance. • Reconciliations: * Reconcile receipts and follow up on incomplete transactions. * Process monthly reports & annual returns. • Follow-up on defaulters: * Follow up on defaulters and dispatch renewal notifications. * Follow up on defaulters of annual returns through inspections. • Database updates and pre-processing: * Processing source exchanges. * Processing import and export authorities. * Process and update information related to inspections. • Radiation over-exposures: * Process radiation over-exposure notifications and escalate to Radiation Scientists as needed. • Radioactive Sources Register: * Compile and update a register for all radioactive sources on the oracle database. 
 
 
INSTRUCTIONS TO APPLICANTS: All applications must: 
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names 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: 26 August 2022 at 16H00.

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MEDICINE REGISTRATION OFFICER: VIGILANCE 
(Clinical Evaluations Management) 
Salary: DPSA Equivalent Level SR 10 (Non-OSD TCE) – R653 613.00 p/a 
Ref No.: SAHPRA 046/2022 
CENTRE: Pretoria 
 
REQUIREMENTS: ● Appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with the South African Pharmacy Council (SAPC) - proof of current registration as a Pharmacist to accompany the application). 
 
Experience: ● Experience within a regulatory environment would be an added advantage (post community service). 
 
COMPETENCIES (KNOWLEDGE, SKILLS & ABILITIES): * Sound and in-depth knowledge of the Medicines and Related Substances Act 101, 1965 as amended and the regulations pertaining to the Act. * Sound knowledge of regulatory scientific and technical requirement (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 and 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: 26 August 2022 at 16H00.

MEDICINE REGISTRATION OFFICER: CLINICAL PRE -REGISTRATION EVALUATIONS 
Salary: DPSA Equivalent Level SR 10 (Non-OSD TCE) – R653 613.00 p/a 
Ref No.: SAHPRA 040/2022 
CENTRE: Pretoria 
 
REQUIREMENTS: ● Appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) - proof of current registration as a Pharmacist to accompany the application) 
Experience: ● At least one year regulatory 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, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge of technical aspects for evaluation of quality and efficacy of bioequivalence of medicines. * Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. * Good planning, organizational and interpersonal skills. * Self-motivated and able to work independently. * Good communication skills (written, verbal, negotiation, conflict management, presentation). * Innovative thinking, initiative, assertive and leadership qualities. * Dedication and accurate work. * Ethical behaviour. * Must be willing to travel and work irregular hours.* Customer service. 
 
DUTIES: ● Evaluation of new applications and peer-reviewing of new applications: * Generate evaluation reports for each new application and submit for peer review in compliance with required template and adopted regulatory /scientific standards (depend on the type of application, i.e., BE and Reliance). * Following peer review process, amend the report accordingly to generate a list of queries to the applicant using the correct templates. * Peer review other evaluators reports according to the required template and adopted regulatory /scientific standards). * Evaluation of PI/PIL applications (new applications and responses). * Prepare query or approval or rejection letter to the applicant. ● Evaluate applicant responses for registration/approval of medicines: * Generate second (and subsequent) evaluation report (s) for each response application 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. ● Develop and update guidelines, SOPs, and templates: * Review existing guidelines, SOPs and templates and update when necessary, and provide and attend trainings on guidelines, SOPs and template to new MROs and external evaluators. * Create new guidelines, SOPs, and templates where relevant. * Provide regular work-plans and output to the Unit Manager (qualitative and quantities report). * Perform any other related 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: * Prepare report for the internal working groups and/or advisory committee and where necessary, present at advisory committee for complex scientific matters and ensure adherence to SOPs and Guidelines. * Provide quality assurance of reports and facilitate resolutions on technical matters. * Align with ICH, WHO, international standards, SAHPRA QMS requirements and use the most current SAHPRA templates and guidelines. * Timeous execution of recommendations from the advisory committee. ● Provide technical advice and information to all stakeholders (internally and externally): * Attend to queries from various stakeholders. * Provide technical advice and information to all stakeholders. * Attend to queries from the Manager, Senior Manager, other Programmes, the Legal Unit and the Chief Regulatory Officer’s office. ● Technical screening of 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 rejection letter to the applicant. * Provide quality assurance of reports and facilitate resolutions on technical matters. 
 
 
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: 26 August 2022 at 16H00.


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​MEDICINE REGISTRATION OFFICER: CLINICAL POST-REGISTRATION EVALUATIONS 
Salary: DPSA Equivalent Level SR 10 (Non-OSD TCE) – R653 613.00 p/a 
Ref No.: SAHPRA 039/2022 
CENTRE: Pretoria 
 
REQUIREMENTS: ● Appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) - proof of current registration as a Pharmacist to accompany the application). ● A relevant NQF 9 qualification in the health sciences will be an added advantage. 
Experience: ● A minimum of 1 year practicing as a pharmacist in a clinical environment (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, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * A solid understanding of the pharmaceutical regulatory environment.. * Computer literacy (MS Office packages). * Supervisory skills. * Good planning, organizational and interpersonal skills. * Good communication skills (written and verbal). * Innovative thinking, initiative, and leadership qualities. * Dedication and accurate work. * Knowledge of database management will be advantageous. * Ability to work well under pressure. * Ability to work in a team. * Good interpersonal qualities. * Must be willing to travel and work irregular hours.* A valid driver’s licence. 
 
DUTIES: ● Evaluation of Variation Applications: * Evaluation and finalization of Type I variation applications.. * Evaluations of Type II variation applications. * Assess submissions for compliance with the interim variation addendum and other clinical guidelines. * Prepare an evaluation report. * Evaluation of pharmacovigilance referrals. * Evaluation of USRN submission for compliance with the USRN guideline where applicable. * Prepare evaluation outcome (recommendations/queries/approval/non-approval) and communicate outcome to Admin/Unit manager. ● Technical Validation / Screening of Variation Applications and Responses: * Ensure priority medicines and urgent applications/responses are screened and identified as such for rapid processing. * Attend to queries from previous and/or current screening cycle. * Ensure that the outcome is captured on the database and a rejection/approval letter sent out to the applicant. * Conduct thorough screening of variation applications for evaluation. * Prepare a screening outcome report and communicate outcome to the Manager. ● Evaluation of Responses to Variations: * Assess submissions for compliance with the variations addendum and other clinical guidelines. * Evaluation of clinical responses from applicants. * Prepare clinical evaluation report. * Prepare evaluation outcome (recommendations/queries/approval/non-approval) and communicate outcome to Admin/Unit Manager. ● Timeous Execution of Recommendations: * Preparation of recommendation for pharmacovigilance referral outcome. * Execution of Advisory Clinical Committee recommendations. * Capturing of ACC Committee recommendations. 
 
 
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: 26 August 2022 at 16H00.

BORDER MEDICINES CONTROL TECHNICIAN (FIXED TERM CONTRACT POSITION: 24 MONTHS) 
Salary: DPSA Equivalent Level SR 7 (Non-OSD) 
Ref No.: SAHPRA 050/2022 
CENTRE: Both Port Elizabeth Airport and Harbour 
 
REQUIREMENTS: ● Advanced Certificate: Pharmacy Technical Support qualification (Registration with SAPC as per current Pharmacy Act Regulations). 
Experience: ● A minimum of 2 years’ experience practicing the scope of the qualification in the pharmaceutical sector. ● Sound and in-depth knowledge of the regulatory compliance requirements in South Africa. 
 
COMPETENCIES, KNOWLEDGE AND SKILLS: * Knowledge and understanding of the Medicines and Related Substances Act, 101 of 1965. * A solid understanding of application procedures. * Planning, organizational and interpersonal skills. * Investigation skills. *.Computer skills and knowledge of MS Office. * Drive and self-management skills. * Communication skills (written, verbal, negotiation, conflict management, presentation). * Resilience. * Assertiveness. * Ethical behaviour. * Must possess a valid driver’s licence. 
 
DUTIES: ● Ensure that all imported health products for release into the Republic of South Africa possess applicable SAHPRA authorizations, e.g. licence, product authorization, certificate or permit. ● Stop the non-compliant health product shipments from entering the country and ensure that necessary processes are undertaken. ● Collaborate with Border control agencies for control of health products. ● Refer to relevant SAHPRA unit any deviations that require Regulatory Compliance Management or Inspectorate intervention. ● Develop, review and ensure implementation of approved Standard Operating Procedures (SOPs) for release / denial of health products at the approved port of entry. ● Work with Port Health and Customs in evaluating, processing and deciding on compliance status and outcome for imported health products. ● Maintaining records by recording and filing daily in the required format all import related documents. ● All activities must be within approved processes within the Regulatory Compliance Unit and report to Manager on improvement measures needed monthly. ● Report performance weekly to the allocated Medicines Control Officer: Regulatory Compliance at SAHPRA Headquarters. ● Submit weekly work-plan and output to the Manager: Regulatory Compliance (quantitative and qualitative reports). ● Participate in monthly meetings with Port Health. ● Prepare reports for consideration of your Medicines Control Officer supervisor, Unit Manager and Senior Manager. 
 
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: 22 August 2022 at 16H00.

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MEDICINE CONTROL OFFICER: INSPECTOR PHARMA (REGULATORY COMPLIANCE) (FIXED TERM POSITION: 24 MONTHS) 
Salary: As per DPSA OSD Framework 
Ref No.: SAHPRA 049/2022 
CENTRE: Pretoria 
 
REQUIREMENTS: • A four-year degree in Pharmacy and registration as a Pharmacist with SAPC (proof of current registration as a Pharmacist to accompany the application). 
Experience: A minimum of 2 years relevant experience as a practicing pharmacist post Community Service. • Sound and in-depth knowledge of the regulatory compliance requirements in South Africa. 
 
COMPETENCIES, KNOWLEDGE AND SKILLS: * A solid understanding of application procedures. * Knowledge and understanding of the international regulators. * Planning and organisational skills. * Interpersonal skills. * Investigation skills. * Computer skills and knowledge of MS Office. * Drive and self-management skills. * Communication skills (verbal, written, negotiation, conflict management, presentation). * Resilience. * Assertiveness. * Ethical behaviour. * Must possess a valid driver’s licence. 
 
DUTIES:
● Plan, organise, perform and report on your activities in enforcing and monitoring compliance to the provisions of the UN Conventions on narcotics and psychotropics i.e. specified Schedule 5 substances, Schedule 6, 7 & 8 substances as per International Narcotics Control Board’s (INCB) reporting requirements: * Reconcile the issued permits on the INCB tracker. * Compile INCB report each quarter and annually on time before due date. * Ensure that data is correct for import, export, manufacture, research and distribution. * Update the INCB tracker as per applicable SOP. ● Plan, organise, perform and report on your activities in enforcing and monitoring compliance to the provisions of the Medicines and Related Substances Act and align with applicable Acts in relation to MEDICAL DEVICES/IVDs: * Develop, review and ensure implementation of approved Standard Operating Procedures (SOPs) for regulatory compliance (law enforcement) of medical devices/IVDs. * Perform activities within approved processes within the Regulatory Compliance Unit and report to manager on Improvement measures needed in relation to medical devices/IVDs. * Participate in risk and audit queries. * Submit weekly work-plan and output to the Manager: Regulatory Compliance (quantitative and qualitative reports). * Prepare reports for consideration by the Manager: Regulatory Compliance, Senior Manager, and Executives. * Prepare reports for the Unit Manager in preparation for SAHPRA and relevant advisory committees. * Investigate complaints regarding contravention of the Medicines Act in relation to medical devices/ IVDs. * Issue warning letters to transgressing companies or individuals by Inspectors in relation to medical devices/IVDs. * Monitoring and control of border posts and mail centres for importation and exportation of health products in relation to medical devices/IVDs. ● Monitor and enforce compliance with the provisions of the Medicines Act and other related Health Acts in relation to MEDICAL DEVICES/IVDs and establish relations with local and international organisations in this regard: * Liaise with SAPS and SARS Customs officials regarding law enforcement. * Conduct training for border management personnel on handling of importation and exportation of medicines. * Communicate with the industry, public and SAHPRA Board, health professional bodies and other stakeholders. * Communication to other government departments and healthcare industry on illegal medical products. * Foster and develop networks on pharmaceutical crime with other regulatory authorities and relevant stakeholders. * Develop and maintain relations with the International Narcotics Control Board and translating requirements for SAHPRA context. * Investigate and attend to industry / applicants’ queries. 
 
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: 22 August 2022 at 16H00.

MEDICINE CONTROL OFFICER: INSPECTOR GMP X2 
(FIXED TERM CONTRACT POSITIONS: 24 MONTHS) 
Salary: As per DPSA OSD Framework 
Ref No.: SAHPRA 047/2022 
CENTRE: Pretoria 
 
REQUIREMENTS: • 4-year Bachelor’s Degree in pharmacy, pharmaceutical sciences, chemistry, medicine, veterinary, biological sciences and biomedical science (Proof of current registration as a Pharmacist must accompany your application if you have a B-Pharm degree). 
Experience: • Minimum of 5 years’ experience in the Pharmaceutical industry or GMP environment (post community service). 
The post-holder must have: • Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment. • Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and all regulations pertaining to the Act. 
 
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. * Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. * Good communication skills (verbal, written, conflict management and resolution). * Delivery of service objectives with professional excellence and efficiency. * Resilience. * 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. * Ability to meet tight deadlines and manage multiple, often competing priorities. * Knowledge of MS Office. * Ethical behaviour and adherence to the SAHPRA Code of Conduct. * Valid Driver’s License.
 
DUTIES: ● Inspect pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA. ● Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured. ● Perform Pre- and Post-Registration inspections on information submitted in a medicine application dossier. ● Perform Once-Off evaluation on information submitted by HCR (Applicants). ● To work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively. ● Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GMP/GWP Guidelines as adopted by SAHPRA. ● To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in the appropriate manner. ● Prepare reports for SAHPRA and relevant advisory committees and the Finance department. ● Liaise with inspectors from international regulatory authorities. ● Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate. ● Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 and medicines quality issues. ● To provide advisory support to key stakeholders, including participation in Regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. ● Record statistics of generated and peer-reviewed reports. ● Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection-related resources and that all relevant records and evidence is sufficiently maintained for audit purposes. 
 
 
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: 22 August 2022 at 16H00.

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MEDICINE CONTROL OFFICER: INSPECTOR GCP X2 
(FIXED TERM CONTRACT POSITIONS: 24 MONTHS) 
Salary: As per DPSA OSD Framework 
Ref No.: SAHPRA 048/2022 
CENTRE: Pretoria 
 
REQUIREMENTS: • 4-year bachelor’s degree in pharmacy, pharmaceutical sciences, chemistry, medicine, veterinary, biological sciences and biomedical science (Proof of current registration as a Pharmacist must accompany your application if you have a B-Pharm degree). 
Experience: • Minimum of 8 years’ experience in a GxP Inspector role, preferably GCP (post community service). 
The post-holder must have: • Extensive knowledge of GxP regulations and industry practice, as well as substantial experience of undertaking GxP inspections within a regulatory environment. • Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and all regulations pertaining to the Act. 
 
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. * Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. * Good 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. * Ability to meet tight deadlines and manage multiple, often competing priorities. * Knowledge of MS Office. * Ethical behaviour and adherence to the SAHPRA Code of Conduct. * Valid Driver’s License. 
 
DUTIES: * Inspect clinical trial vendors, laboratories, and other identified sites for compliance with Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs) as accepted by SAHPRA. * Assess and evaluate GCP inspection reports of other regulatory authorities on international bioequivalent trials to verify clinical data to support registration of medicines in South Africa. * To work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively. * Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GCP Guidelines as adopted by SAHPRA. * To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in the appropriate manner. * Prepare reports for SAHPRA and relevant advisory committees and the Finance department. * Liaise with Inspectors from international  regulatory authorities. * Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate. * Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965. * To provide advisory support to key stakeholders, including participation in Regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. * Record statistics of generated and peer-reviewed reports. 
 
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: 22 August 2022 at 16H00.