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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
MEDICINE REGISTRATION OFFICER: Clinical Trials
SALARY: R653 613.00 - R769 914.00
Ref No.: SAHPRA 062/2022
CENTRE: Pretoria
REQUIREMENTS: • A 4-year Bachelor of Pharmacy degree and registration with the South African Pharmacy Council (SAPC) as a Pharmacist. • A relevant post-graduate qualification in the health sciences will be an advantage.
EXPERIENCE: • B-Pharm degree, registration as a Pharmacist with a minimum of 8 years’ appropriate experience (Current registration as a Pharmacist must be submitted with the application)
COMPETENCIES, KNOWLEDGE AND SKILLS: * 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 requirements (in terms of quality, safety and efficacy aspects). * Good knowledge of the conduct of clinical trials. * Comprehensive knowledge and understanding of international regulatory clinical trials guidelines. * Computer skills (knowledge of MS Office). * Planning and organisational 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 clinical trials protocol applications and applicant responses. * Co-ordinate clinical trials activities and committee meetings. * Supervise administrative staff and attend to queries addressed to the Clinical Trials Unit. * Provide technical assistance and support to appropriate Advisory Committee/s and SAHPRA generally. * Develop Standard Operating Procedures (SOPs) for conducting clinical trials as well as related policies and guidelines. * Technical screening and allocation of new clinical trials applications. * Review of Serious Adverse Events and progress reports reported during the conduct of clinical trials. * Review any other clinical trials correspondence. * Liaise with applicants and advisory committee members. * Investigate and attend to pharmaceutical industry / applicants’ queries. * 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: 22 November 2022 at 16H00.
MEDICINE REGISTRATION OFFICER: Clinical Trials
SALARY: R653 613.00 - R769 914.00
Ref No.: SAHPRA 062/2022
CENTRE: Pretoria
REQUIREMENTS: • A 4-year Bachelor of Pharmacy degree and registration with the South African Pharmacy Council (SAPC) as a Pharmacist. • A relevant post-graduate qualification in the health sciences will be an advantage.
EXPERIENCE: • B-Pharm degree, registration as a Pharmacist with a minimum of 8 years’ appropriate experience (Current registration as a Pharmacist must be submitted with the application)
COMPETENCIES, KNOWLEDGE AND SKILLS: * 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 requirements (in terms of quality, safety and efficacy aspects). * Good knowledge of the conduct of clinical trials. * Comprehensive knowledge and understanding of international regulatory clinical trials guidelines. * Computer skills (knowledge of MS Office). * Planning and organisational 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 clinical trials protocol applications and applicant responses. * Co-ordinate clinical trials activities and committee meetings. * Supervise administrative staff and attend to queries addressed to the Clinical Trials Unit. * Provide technical assistance and support to appropriate Advisory Committee/s and SAHPRA generally. * Develop Standard Operating Procedures (SOPs) for conducting clinical trials as well as related policies and guidelines. * Technical screening and allocation of new clinical trials applications. * Review of Serious Adverse Events and progress reports reported during the conduct of clinical trials. * Review any other clinical trials correspondence. * Liaise with applicants and advisory committee members. * Investigate and attend to pharmaceutical industry / applicants’ queries. * 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: 22 November 2022 at 16H00.
X-RAY INSPECTOR
(Salary: R744 255.00 – R789 930.00)
Ref No.: SAHPRA 059/2022
CENTRE: Pretoria
REQUIREMENTS: * BSc degree with honours in Medical Physics. * Professional registration with the HPCSA (Proof to be submitted with application).
Experience: * Minimum experience of 5 years working as Medical Physicist in Radiation Oncology and/or Nuclear Medicine and/or Diagnostic Radiology. * Working 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. * 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. * MS Office. * Aptitude tests will be conducted. * A valid driver’s licence.
DUTIES: • Operations and processes of the subunit: * 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 subunit. • 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’ equipments 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, codes of conduct 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: 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 afore mentioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date and time, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 23 November 2022 at 16H00.