Job Opportunities at South African Health Products Regulatory Authority

REQUIREMENTS: 

• Applicants must be in possession of a Matric certificate and Advanced Certificate: Pharmacy Technical Support qualification and are registered with the South African Pharmacy Council (SAPC) as per current Pharmacy Act Regulations.

EXPERIENCE:

• A minimum of 2 years’ experience practising as a Pharmacy Technician/Post-Basic Pharmacist Assistant. 
• Knowledge of medical products quality assurance including interpretation, evaluation and analysis of laboratory testing reports and inform decision-making.

DUTIES: 

• Ensure that all imported health products for release into the Republic of South Africa possess applicable SAHPRA authorisations, e.g. licence, product authorisation, certificate or permit. 
• Stop non-compliant health product shipments from entering the country and ensure that necessary processes are undertaken. 
• Collaborate with Border control agencies for the control of health products. 
• Refer any deviations that require Regulatory Compliance Management or Inspectorate intervention to the relevant SAHPRA unit. 
• 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 daily filing in the required format of all import related documents. 
• All activities must be within approved processes within the Regulatory Compliance Unit and report to the Manager on improvement measures needed monthly. 
• Report performance weekly to the allocated Medicines Control Officer: Regulatory Compliance at SAHPRA’s Head Office. 
• 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.

go to method of application »

REQUIREMENTS:

• Matric certificate and appropriate four-year degree in Pharmacy at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA) and registration with a Professional Body (South African Pharmacy Council). A relevant Master’s degree will be an added advantage. A valid driver’s licence.  

EXPERIENCE:

• Grade 1 – A minimum of two (2) years of Pharmacovigilance experience post internship and Community Service. Regulatory experience will be an added advantage. 
• Grade 2 –A minimum of five (5) years of Pharmacovigilance experience post internship and Community Service. 

DUTIES:

• Operational Management: Responsible for the accurate and timeous assessment of safety documents received, and performance as per the defined processes. Preparing comprehensive reports for various purposes (e.g., regulatory submissions, advisory committees, internal communication). Preparing accurate, timely, and well-documented reports that meet regulatory requirements. Documenting decision-making processes and justifications. Writing clear, concise, and evidence-based reports. Producing scientific peer-reviewed evaluation reports. Provide technical and administrative support to committees. Engaging stakeholders relating to regulatory matters. Manage product review systems. Processing applications received for approval. 
• Support the AEFI management: Conduct case management and causality assessments for AEFI cases for all registered vaccines. Establish integrated procedures and processes for monitoring, reporting and assessment of vaccine-related safety concerns. Train healthcare professionals in the provinces on AEFI management, causality assessment and AEFI reporting procedures and tools. Review, update and implement updated procedures and processes for the management of registered vaccines. 
• Support Pharmacovigilance (PVC) and National Immunisation Safety Expert Committee (NISEC): Support the PVC/NISEC both technically and administratively. Coordinate all PVC/NISEC meetings and minutes thereof. Allocate case files for clinical assessment to both pharmacovigilance technical officers and NISEC members. Update AEFI cases on reports management system as per the NISEC causality assessment outcome. Prepare and provide monthly reports/statics on AEFI cases. Ensure case closure and provision of feedback to the provinces. Prepare and communicate all regulatory decisions as per the meeting discussions. 
• Coordinate and support provinces on vaccines and therapeutics safety reporting and case management: Support and strengthen linkages with provincial Departments of Health (DoH) to facilitate SAHPRA decentralised pharmacovigilance activities. Implement procedures and strengthen coordination with provincial and district-level DoH staff to improve AEFI and ADR reporting and case management activities. Develop/update reporting procedures for both AEFIs and therapeutics ADRs and co-ordinate finalisation. Strengthen provincial safety committees and linkages to SAHPRA. 
• Training and outreach: Co-ordinate and implement trainings for healthcare professionals in both private and private sectors. Co-ordinate medicine safety awareness webinars and workshops. Work closely with provinces and stakeholders for planning and implementation of outreach programmes for both healthcare professionals and the public. 
• Benefit-Risk Evaluation: Critically assess Risk Management Plans (RMP)/Periodic Benefit-risk Evaluation Reports (PBRER)/Periodic Safety Update Reports (PSUR)/Summary of Benefit-Risk Evaluation reports/Safety signals as submitted by applicants or received from any other stakeholder. Write clear, concise, and evidence-based reports. Produce scientific peer-reviewed scientific reports for discussion. Timeous preparation and submission of assessment reports to ensure compliance with targets and timelines. Prepare and publish safety-related communications timeously.
•  ICSR Management: Processing and management of ADR/ADE reports received. Clinical assessment of serious adverse reaction reports. Co-ordinate and participate in causality assessment meetings of serious cases and cases of public interest. Conduct signal detection/assessment and necessary investigation. 
• Financial Management: Collating, compiling, and submitting accurate reports in a timely manner to satisfy statutory and business requirements as well as be able to communicate key financial messages to stakeholders with clarity and consistency. Provide general advice on all related financial matters to all relevant colleagues involved, directly or indirectly, in the financial circuit. Monitors and maintains all required financial records for compliance and audit to all agreed requirements. Collate financial data and reports for analysis and to facilitate decision making. 
• Governance, Compliance and Risk: Achieve and maintain process quality. Adherence with the OHSA to ensure a safe and healthy working environment. Ensure adherence to all process quality assurance requirements. Assist with Performance Reporting within the predetermined timeline. Identify and record operational risks and consult with the Unit Manager. Mitigate risks within operational control. Resolve the operational risks effectively and timeously. Filing of evaluation reports under respective product folders. Assisting with the compliance of the Quality Management System requirements of the unit. Identify and record operational risks and consult with Unit Manager. 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 to maintain consistency, efficiency and alignment of PV processes. Update policy documents to improve and maintain high levels of operational efficiency and effectiveness.
•  People Management: Self-management. Manage own Performance and Individual Development Plan. Living the SAHPRA values. Sharing knowledge with and informal coaching peers (as applicable). 

go to method of application »

REQUIREMENTS: 

• Matric certificate and appropriate 4-year Degree in Pharmacy at NQF level 8 as recognised by SAQA and registration as a Pharmacist with a Professional Body (SAPC) or 4-year science degree in a health science related field at NQF level 8 as recognised by SAQA from a recognized university or tertiary institution. A valid driver’s license.  

EXPERIENCE:

• At least one-year regulatory experience (post community 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.