Career Opportunities at South African Health Products Regulatory Authority

REQUIREMENTS: 

• Applicants must be in possession of a Matric certificate and appropriate four-year Bachelor of Pharmacy degree and registration as a pharmacist with the South African Pharmacy Council (SAPC) at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA)
• or an Honours degree in related health sciences at NQF level 8 as recognised by SAQA.
• A relevant master’s qualification at NQF Level 9 as recognised by SAQA will be an added advantage. Valid driver’s licence. 

EXPERIENCE

• Grade 1: Four-year Bachelor of Pharmacy degree at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC plus a minimum of three (3) years regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance; OR an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA plus a minimum of five (5) years regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 
• Grade 2: Four-year Bachelor of Pharmacy degree at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC plus a minimum of five (5) years regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance OR an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA plus a minimum of eight (8) years regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 

DUTIES:

• Evaluation of new applications and peer-reviewing of new applications: Generate evaluation report(s) for each new application (new chemical entities (NCE) and Generics) in compliance with required template and adopted regulatory/scientific standards and submit for peer review. Following the peer review process, amend the report(s) accordingly to generate a list of queries to the applicant using the correct templates. Peer-review primary report(s) compiled by other reviewers. Prepare reports for the internal working groups and where necessary present at advisory committee for complex scientific matters. Prepare query letters to applicants. Prepare a basis of approval or rejection. Provide quality assurance of reports and facilitate resolutions on technical matters. 
• Evaluate applicant responses for registration/approval of medicines: Generate second (and subsequent) evaluation reports for each response application and submit for peer review in compliance with required template and adopted regulatory/scientific standards and submit for peer review. Following the 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. Prepare reports for the internal working groups and where necessary present at advisory committee for complex scientific matters. Prepare query letters to applicants. Prepare a basis of approval or rejection. Provide quality assurance of reports and facilitate resolutions on technical matters. 
• Technical screening for the quality and efficacy (bioequivalence) aspects of new applications for the registration of medicines: Generate technical screening evaluation reports for each application and submit for peer review. Following the peer review process, amend the technical screening reports accordingly to generate a list of queries to the applicant using the correct templates. Peer review technical screening reports compiled by other reviewers. Prepare screening query/screening rejection letter to the applicant. Provide quality assurance of reports and facilitate resolutions on technical matters. 
• Develop and update guidelines, SOPs and templates: Review existing guidelines, standard operating procedures (SOPs) and templates and update when necessary. Provide training on guidelines, SOPs and templates. 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 the manager/senior manager. 
• Form part of technical working groups or special projects and also provide support to the unit as well as to advisory committees: Participate in special projects and registration groups. Lead and manage assessments peer review and discussion working group where relevant. Compile discussion documents and reports. Provide regular training to new internal medicine registration officers (MROs) and external evaluators. Take comprehensive notes of discussions of relevant discussions. Prepare documents for the SAHPRA management/RC meetings. 
• Risk Management and Audit: Adhere to SOPs and Guidelines. Create and maintain databases. Use the most current templates and guidelines. Provide and attend relevant training as may be necessary. Align with Quality Management System requirements. Align with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, World Health Organisation, International Pharmaceutical Regulators Programme and other international standards.

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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 Occupational Health and Safety Act (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).