SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

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MEDICINES REGISTRATION OFFICER - PHARMACOVIGILANCE (FIXED TERM CONTRACT POSITION: 24 MONTHS) 
SALARY: R788 910.00 – R837 326.00 (TOTAL COST TO COMPANY) 
Ref No.: SAHPRA 038/2023 
CENTRE: Pretoria 
 
REQUIREMENTS: • Appropriate 4-year Bachelor of Pharmacy Degree from a recognised university or tertiary institution (Current registration with the SAPC as a Pharmacist must be submitted with the application). • A postgraduate qualification in relevant Science or equivalent is an added advantage. 
 
EXPERIENCE: • A minimum of 8 years experience. • Training and experience in pharmacovigilance. • 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 medical industry communications and articles. 
 
COMPETENCIES, KNOWLEDGE AND SKILLS: * Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act, Act 101 of 1965. * Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. * 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. * Good planning and organisational skills. * Ability to work unsupervised for long periods of time. * Promoting a more proactive, service oriented and performance-based management culture. * Good, effective communication skills (verbal, written, conflict management and resolution). * Ability to meet tight deadlines and manage multiple, often competing priorities. * Ability to work within a team environment. * Ethical behaviour and adherence to the SAHPRA Code of Conduct. * Proficient knowledge of MS Office. *A valid Driver’s License. 
 
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: 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: 04 September 2023 at 16H00.
 
 
 
 

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MEDICINES REGISTRATION OFFICER - PHARMACOVIGILANCE 
SALARY: R788 910.00 – R837 326.00 (TOTAL COST TO COMPANY) 
Ref No.: SAHPRA 037/2023 
CENTRE: Pretoria 
 
REQUIREMENTS: • Appropriate 4-year Bachelor of Pharmacy Degree from a recognised university or tertiary institution (Current registration with the SAPC as a Pharmacist must be submitted with the application). • A postgraduate qualification in relevant Science or equivalent is an added advantage. 
 
EXPERIENCE: • A minimum of 8 years experience. • Training and experience in pharmacovigilance. • 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 medical industry communications and articles. 
 
COMPETENCIES, KNOWLEDGE AND SKILLS: * Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act, Act 101 of 1965. * Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. * 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. * Good planning and organisational skills. * Ability to work unsupervised for long periods of time. * Promoting a more proactive, service oriented and performance-based management culture. * Good, effective communication skills (verbal, written, conflict management and resolution). * Ability to meet tight deadlines and manage multiple, often competing priorities. * Ability to work within a team environment. * Ethical behaviour and adherence to the SAHPRA Code of Conduct. * Proficient knowledge of MS Office. *A valid Driver’s License. 
 
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: 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: 04 September 2023 at 16H00.




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DEPUTY MANAGER: RADIONUCLIDES 
Ref No.: SAHPRA 043/2023 
SALARY LEVEL 12 : R 934 965 – 992 341 
CENTRE: CAPE TOWN (WESTERN CAPE) 
 
REQUIREMENTS:
• B.Sc. (Hons) degree in Medical Physics or M.Sc. in Nuclear Science (or similar). 
• HPCSA professional registration (where applicable) 
• A minimum of three (3) years of managerial experience in any combination of the four fields (Radiation Oncology, Diagnostic Radiology, Nuclear Medicine, and Radiation Protection). 
• Working knowledge of 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. * Attention to detail. * Self-motivated and able to work independently. * Competent in problem-solving, research skills and team building. * 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. * MS Office. * Aptitude tests will be conducted.
 
DUTIES:
Developing effective operational strategies for licensing, inspections and enforcement related to radioactive sources, in collaboration with the Inspectorate Sub-unit. 
Maintaining oversight of (and accountability for) licensing radioactive sources, non-compliances and enforcement policies related to the regulation, safety, and security of radioactive sources, in collaboration with Deputy Managers: Inspectorate and Electronic Generators of Ionizing Radiation (“X-Rays”). * Supporting the coordination of functions between the sub-units i.e., (X-Rays) and Inspectorate * Conducting needs analyses and providing inputs to budget and acquisition of assets, consultants, and contractors. * .Providing staff leadership, performance management, quality management, risk management and skill and career development, motivation, discipline, and dealing with complaints/grievances. * Collating and submitting analyses and reports in accordance with standard procedures and prescribed formats. 
 
Ensures effectiveness of internal/sub-unit operational processes by: Ongoing review and optimisation of operations and processes. * Developing, reviewing, and improving the accuracy of databases. * Coordinating operations, processes, and projects within the sub-unit. * Encouraging effective utilisation of resources to enhance value for money. * Developing (and reviewing) internal policies, in collaboration with management. * Evaluating and improving security (physical, information, cyber). 
 
Ensures the appropriate development, evaluation, and continuous improvement of regulatory control by: Advising on and leading processes to improve regulatory control and cooperative governance. * Supporting, coordinating, and participating in research projects and new developments in these fields. * Supporting, coordinating, and participating in national and regional technical cooperation projects. * Developing, reviewing, and improving regulatory management system. 
 
Builds human capital in the sub-unit by: Working with the Manager and relevant functional heads to develop plans and procedures for information and knowledge management and the sourcing, acquisition, and development of staff with required critical skills. 
 
Implements internal communication and incident reporting procedures by: Liaising with management, and the legal and communications departments for advice and to clarify established SAHPRA systems and methodologies. * Providing comments, inputs and advice on international standards and guidance documents, representing the interests of South Africa as member state of the IAEA, under the guidance of senior management and in collaboration with medical physicists and radiation scientists. * Managing investigation of incidents and accidents, and the formulation of appropriate communications with licensees, other regulatory authorities, and the public, in collaboration with the Deputy Managers: Inspectorate and Electronic Generators of Ionizing Radiation (“X-Rays”) under the guidance of the Manager: Radiation Control. * Representing SAHPRA interests on national, regional, and international levels (forums, committees, etc.). 
Licensing the import and manufacture of group IV hazardous substances in terms of the Hazardous Substances Act:  Check that the import/manufacture of any group IV hazardous substances complies with the regulatory requirements related to the Hazardous Substances Act. * Check annually that the compliance documentation supporting issuing any such licence remains current and valid. Compile high-level monthly and quarterly reports of the sub-unit. 
 
Attending to regulatory and technical queries:  Respond to or initiate queries related to the licensing of listed electronic products. * Respond to queries related to non-ionising radiation issues. 
 
Developing and implementing policy, SOPs, and guidelines:  To develop and implement policy with respect to the regulatory control of listed electronic products. * To develop and implement SOPs and guidelines with respect to the regulatory control of listed electronic products. * Management of the sub-unit Quality Systems. 
 
Managing operational risk & audit queries: To respond to risk and audit queries as required. * Manage and compile operational risk and record registers. 
 
 
INSTRUCTIONS TO APPLICANTS: All applications must: 
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s. 
 
• Applications without the afore mentioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA). 
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications. 
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS. 
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered. 
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful. 
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA. 
 
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment. 
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s. 
 
Enquiries: Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS). 
 
CLOSING DATE: 31 August 2023 at 16H00.