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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.
MEDICAL DEVICES - MEDICINE REGISTRATION OFFICER: LICENSING
DPSA Equivalent Non OSD: TCE SL Level 10 (+ in leu of 37% benefits)
Ref No: SAHPRA 043/2022 Permanent
CENTRE: Pretoria
REQUIREMENTS:
• An appropriate 4-year Pharmacy Degree or equivalent NQF level 7 or Life Sciences
• At least two (2) years’ regulatory experience in Medical Devices including IVDs
• An understanding of Medical Devices Vigilance requirements
COMPETENCIES/ATTRIBUTES REQUIRED:
• Sound knowledge of regulatory scientific and technical requirement of medical Devices (including IVDs)
• Knowledge of quality, safety and efficacy aspects of medical Devices (including IVDs).
• An understanding of the Medical Device Establishment licensing requirements, Pre- and Post-Marketing Surveillance processes
• Preparation and management of operational and tactical plans, and budgeting
• Computer literacy and MS Windows computer skills, Excel and database applications
• Good report writing and presentation skills
• Good planning, organizational and 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 details and Information evaluation
DUTIES:
Technical requirements: *Develop and maintain guidelines and standard operating procedures for medical device and IVD registration. *Evaluate and manage licence applications for medical device establishments and maintain relevant databases. *Evaluate and manage applications and request for advertising and promotional material* Management of queries management database (technical)*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 quality issues. *Investigate and attend to industry / applicant’s queries. *Perform other 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. *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).
Evaluation and Risk Management: Investigate non-compliance to the Medicines and Related Substances Act 101 of 1965 as amended, General Regulations, Medical Device Regulations, internal processes. * Ensure all identified CAPA’s are implemented as per agreed (tasks and timelines). * Peer-review reports done by other reviewers. * Attend, present, and participate in peer-review and Regulations and licensing working groups/Committee discussions. * Compile minutes and or reports of peer reviewed discussion and recommendations as applicable.
Partnerships, Collaboration & Communication: Prepare and attend Industry engagements and other Regulatory Forums. * Respond to stakeholder queries timeously. * Review and facilitate the finalization and publication for Media Release, & Newsletters as per request from the 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 of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Email: Matshepo.mokotong@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 15 August 2022 at 16H00
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.
MEDICAL DEVICES - MEDICINE REGISTRATION OFFICER: LICENSING
DPSA Equivalent Non OSD: TCE SL Level 10 (+ in leu of 37% benefits)
Ref No: SAHPRA 043/2022 Permanent
CENTRE: Pretoria
REQUIREMENTS:
• An appropriate 4-year Pharmacy Degree or equivalent NQF level 7 or Life Sciences
• At least two (2) years’ regulatory experience in Medical Devices including IVDs
• An understanding of Medical Devices Vigilance requirements
COMPETENCIES/ATTRIBUTES REQUIRED:
• Sound knowledge of regulatory scientific and technical requirement of medical Devices (including IVDs)
• Knowledge of quality, safety and efficacy aspects of medical Devices (including IVDs).
• An understanding of the Medical Device Establishment licensing requirements, Pre- and Post-Marketing Surveillance processes
• Preparation and management of operational and tactical plans, and budgeting
• Computer literacy and MS Windows computer skills, Excel and database applications
• Good report writing and presentation skills
• Good planning, organizational and 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 details and Information evaluation
DUTIES:
Technical requirements: *Develop and maintain guidelines and standard operating procedures for medical device and IVD registration. *Evaluate and manage licence applications for medical device establishments and maintain relevant databases. *Evaluate and manage applications and request for advertising and promotional material* Management of queries management database (technical)*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 quality issues. *Investigate and attend to industry / applicant’s queries. *Perform other 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. *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).
Evaluation and Risk Management: Investigate non-compliance to the Medicines and Related Substances Act 101 of 1965 as amended, General Regulations, Medical Device Regulations, internal processes. * Ensure all identified CAPA’s are implemented as per agreed (tasks and timelines). * Peer-review reports done by other reviewers. * Attend, present, and participate in peer-review and Regulations and licensing working groups/Committee discussions. * Compile minutes and or reports of peer reviewed discussion and recommendations as applicable.
Partnerships, Collaboration & Communication: Prepare and attend Industry engagements and other Regulatory Forums. * Respond to stakeholder queries timeously. * Review and facilitate the finalization and publication for Media Release, & Newsletters as per request from the 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 of 3 referees and recently certified copies of ID and qualification/s.
• Applications without the aforementioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Email: Matshepo.mokotong@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 15 August 2022 at 16H00
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 EVALUATION MANAGEMENT (PRE & POST) AND PHARMACEUTICAL EVALUATION MANAGEMENT (PRE & POST) X15 (FIXED TERM CONTRACT POSITIONS: 24 MONTHS)
Salary: As per DPSA OSD Framework
Ref No.: SAHPRA 041/2022
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) OR 4-year Science Degree in a health science related field from a recognised university or tertiary institution. ● A relevant NQF 9 qualification in the health sciences will be an added advantage.
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 / variations: * 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., Full/partial reviews Q-BE and Reliance. * Evaluation of Type I and II clinical/quality variation applications. * Following peer review process, amend the report accordingly to generate a list of queries to the applicant using the correct templates (Full/partial reviews Q-BE and reliance). * Peer review other evaluators reports according to the required template and adopted regulatory /scientific standards (Full/partial reviews Q-BE and reliance). * 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, IPRP, 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: 12 August 2022 at 16H00.