SAQA All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.
SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED QUALIFICATION: 

Occupational Certificate: Health Products Vigilance Officer (HPVO) 
SAQA QUAL ID QUALIFICATION TITLE
125112  Occupational Certificate: Health Products Vigilance Officer (HPVO) 
ORIGINATOR
Development Quality Partner - CHIETA 
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY NQF SUB-FRAMEWORK
QCTO - Quality Council for Trades and Occupations  OQSF - Occupational Qualifications Sub-framework 
QUALIFICATION TYPE FIELD SUBFIELD
Part-Qualification  Field 09 - Health Sciences and Social Services  Curative Health 
ABET BAND MINIMUM CREDITS PRE-2009 NQF LEVEL NQF LEVEL QUAL CLASS
Undefined  46  Not Applicable  NQF Level 05  Regular-ELOAC 
REGISTRATION STATUS SAQA DECISION NUMBER REGISTRATION START DATE REGISTRATION END DATE
Registered  EXCO 0936/25  2025-11-13  2029-11-13 
LAST DATE FOR ENROLMENT LAST DATE FOR ACHIEVEMENT
2030-11-13   2033-11-13  

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.  

This qualification does not replace any other qualification and is not replaced by any other qualification. 

PURPOSE AND RATIONALE OF THE QUALIFICATION 
Purpose:
The purpose of Occupational Certificate: Health Products Vigilance Officer (HPVO) part qualification is to prepare a learner to operate as a Health Product Vigilance Officer.

A Health Products Vigilance Officer (HPVO) conducts vigilance and post-marketing surveillance activities in a health product regulatory environment. They ensure registered and licensed health products are continuously safe to use by monitoring the occurrence of adverse events and assisting with requests for product recall. Health products include medicines, medical devices and in vitro devices (IVDs), veterinary and personal care products. These applications are submitted to the regulatory body electronically in the main.

A qualified learner will be able to:
  • Conduct / perform vigilance and post marketing surveillance.

    Achieving this Health Products Vigilance Officer (HPVO) qualification will provide several benefits to the learner, including:
  • Acquiring in-depth knowledge of vigilance and post-marketing surveillance activities with respect to health products.
  • Taking a significant step into the health products sector with the prospect of acquiring higher or related qualifications in the field.
  • Acquisition of a formal qualification in vigilance and post-marketing surveillance with respect to health products, if learner does not already have a qualification.
  • Increasing the opportunity of gaining employment with companies that manage health product applications for registration and licensing. Considering South Africa's huge unemployment rate, a qualification like this has the potential to get learners into meaningful employment.

    Typical graduate attributes include proficiency, efficiency, and effectiveness in carrying out the important functions of assisting a Responsible Pharmacist or Authorised Person to complete and submit adverse reaction/event reporting forms and health product recall documents to the regulatory body. The Health Products Vigilance Officer (HPVO) is a person of integrity and high ethical standards as they work within a regulatory framework to ensure the safety of the public from harmful health products.

    Rationale:
    No health product may be sold in South Africa unless it has been registered with an appropriate regulatory body. This qualification covers medicines, medical devices and in vitro devices (IVDs), complementary medicines, personal care products and veterinary products. Currently, the South African Health Products Authority (SAHPRA) registers health products as defined by the Medicines Act 101 of 1965 and its Amendments - whether they are manufactured locally or abroad - to ensure safety, efficacy, and quality

    A health product can only be marketed once it is registered by SAHPRA. However, clinical trials which are performed to identify safety issues of a health product before its registration cannot completely identify all the reactions to a health product. This is done by monitoring the use of a product through vigilance and post-marketing surveillance.

    This qualification plays a very critical role in monitoring the use of a product through vigilance and post-marketing surveillance. In spite of the critical role of the HPVO, there is no qualification registered on the NQF for this much-needed occupation. This is the first time a qualification for this occupation is being developed. Current training is disparate and carried out by companies that register and market health products. There is a need to standardise such disparate training and set the benchmark for the occupation.

    There are no similar Qualification(s) and Part-Qualifications registered on the NQF, and no Skills Programmes approved by the QCTO

    As the number of health products grows significantly in view of scientific advancement (the plethora of health products being a case in point), the Health Products Vigilance Officer part qualification becomes critical to both fulfil the needs of the country for safe health products and standardise current but disparate training offered by companies dealing in health products.

    Another significant aspect is that the part qualification will contribute to ensuring that health products are safe to use by monitoring their effects. HPRAs will be qualified to apply SAHPRA's criteria for vigilance and surveillance.

    The qualification has the potential of creating employment as it is needed in the industry and there is a potential uptake of the qualification by significant number of learners. Increased employment will translate into increased benefits for the economy.

    Typical learners will be those currently practising as Health Products Vigilance Officers who have been operating without training on a formal qualification. Other learners could include matriculants or those with a relevant higher education qualification wishing to enter the health product regulatory sector.

    In the development of this qualification, the following stakeholders were consulted:
  • Training providers
  • Regulator
  • Employers/employer organisations 
    		•

    LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
    Recognition of Prior Learning (RPL):
    RPL for Access to Training:
    Learners may use the RPL process to gain access to training opportunities for a programme of learning, part-qualification if they do not meet the formal, minimum entry requirements for admission. RPL assessment provides an alternative access route into a programme of learning, part-qualification. Such an RPL assessment may be developed, moderated and conducted by the accredited Skills Development Provider which offers that specific part qualification. Such an assessment must ensure that the learner is able to display the equivalent level of competencies required for access, based on the NQF level descriptors.

    RPL for Access to the External Integrated Summative Assessment (EISA)
    For exemption from modules through RPL, learners who have gained the stipulated competencies of the modules of a programme of learning, part-qualification through any means of formal, informal or non-formal learning and/or work experience, may be awarded credits towards relevant modules, and gaps identified for training, which is then concluded.

    Entry Requirements
  • An NQF Level 4 qualification, with Mathematics and Science. 
    		•

    RECOGNISE PREVIOUS LEARNING? 
    Y 

    QUALIFICATION RULES 
    This qualification is made up of compulsory Knowledge, Practical Skill and Work Experience Modules:

    Knowledge Modules:
  • 242213-001-00-KM-01, Overview of Current Health Products Industry/Sector, NQF Level 5, 5 Credits.
  • 242213-001-00-KM-02, Anatomy and Physiology, NQF Level 5, 10 Credits.
  • 242213-001-00-KM-03, Health Products, NQF Level 5, 8 Credits.
  • 242213-001-00-KM-04, Science for the Health Product Regulatory Assistant (HPRA), NQF Level 5, 3 Credits.
  • 243302-001-00-KM-07, Vigilance and Post Marketing Surveillance, NQF Level 5, 6 Credits.

    Total number of credits for Knowledge Modules: 32

    Practical Skill Modules:
  • 242213-001-00-PM-03, Conduct Oneself Professionally and Ethically, NQF Level 4, 3 Credits.
  • 242213-001-00-PM-04, Perform Vigilance and Post Marketing Surveillance, NQF Level 5, 5 Credits.

    Total number of credits for Practical Skill Modules: 8

    Work Experience Modules:
  • 242213-001-00-WM-05, Processes to Perform Vigilance and Post Marketing Surveillance, NQF Level 5, 6 Credits.

    Total number of credits for Work Experience Modules: 6 
    		•

    EXIT LEVEL OUTCOMES 
    1. Conduct / perform vigilance and post marketing surveillance to ensure the safe usage of health products. 

    ASSOCIATED ASSESSMENT CRITERIA 
    Associated Assessment Criteria for Exit Level Outcome 1:
    ELO 1: Conduct / perform vigilance and post marketing surveillance to ensure the safe usage of health products.
  • Explain concepts, definitions and terminology associated with vigilance.
  • Complete adverse reaction/event reporting forms in an assistive capacity and submit to the regulatory body through its appropriate submission procedure/mechanism.
  • Implement a health product recall assignment in an assistive capacity according to standard operating procedures.
  • Prepare a report on vigilance in an assistive capacity as per standard operating procedures.
  • Prepare recall letters and media releases in an assistive capacity and sent to the industry, standard operating procedures.

    Integrated Assessment
    Integrated Formative Assessment:
    Formative assessments are conducted throughout the training of learners. A range of formal, nonformal, and informal ongoing assessment activities is used to focus on teaching and learning outcomes to improve learner attainment.

    Formative assessments are conducted continuously by the facilitator to feed into further learning, to identify strengths and weakness, and to ensure the learner's ability to apply knowledge, skills and workplace experience gained.

    Formative Assessments are conducted by the accredited Skills Development Provider (SDP), and a variety of ongoing assessment methods may be used, for example, quizzes, assignments, tests, scenarios, role play, interviews. Continuous feedback must be provided.

    Integrated Summative Assessment:
    Integrated Assessment involves all the different types of assessment tasks required for a particular part- qualification, such as written assessment of theory and practical demonstration of competence. To achieve this, the Internal Assessment Criteria (IAC) for all modules as found in the QCTO curriculum document must be followed.

    An accredited SDP should implement a well-designed, formal, relevant, final internal Summative Assessment strategy for all modules to prepare learners for the EISA. These assessments evaluate learning achievements relating to the achievement of each module of the relevant components of the part-qualification.

    Internal Summative Assessments are developed, moderated, and conducted by the SDP at the end of each module or after integration of relevant modules, e.g., applied knowledge tests, workplace tasks, practical demonstrations, simulated tasks/demonstrations, projects, case studies, etc 
    		•

    INTERNATIONAL COMPARABILITY 
    An international comparability study is undertaken in Canada and the United States to identify qualifications or courses similar to this qualification in terms of scope, cognitive levels and content of the curricula.

    Canada
    The Regulatory Affairs Professionals Society (RAPS) Online University offers a number of certificates and courses; two such courses are: the Regulatory Affairs Dual Certificate in Medical Devices and Pharmaceuticals and the Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals.

    Institution: The Regulatory Affairs Professionals Society (RAPS)
    Qualification: Regulatory Affairs Dual Certificate in Medical Devices and Pharmaceuticals and Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals.

    Entry requirements: Not specified.

    There is, however, no specific course or academic programme for the Health Product Vigilance Officer but there are modules that resonate with the South African qualification. Canada does not have a NQF structure, the fact that the certificates cited above are at university level indicates that courses and the modules below could presumably be at South African NQF Level 5 or 6.

    The modules are:
  • Ethics
  • Role of the Regulatory Professional
  • Ethics - Essential Tools for Regulatory Professionals
  • Medical Devices: Post-market Surveillance
  • Pharmacovigilance
  • Effective Regulatory Communication

    Similarities:
    The above set of modules when taken cumulatively closely resembles the HPVO qualification. The above similarities are based on the availability of appropriate modules that can be used to constitute a course that is similar to the South African qualification.

    Differences:
    There are no differences because there is no specific course dedicated to Health Product Vigilance in the Canadian offerings.

    United States
    Institution: The Certified Clinical Research Professionals Society (CCRPS)
    Qualification: Advanced International Pharmacovigilance and Argus Safety Certification (APVASC).
    Duration: The average learning time is around 4 weeks, but learners can take up to 12 weeks to complete.
    Entry requirement: The entry requirements are not specified.

    Module 1 - Fundamentals of Global Pharmacovigilance:
  • Introduction to Drug Safety and PV
  • Key PV Terminology (Side Effect, Drug Safety and Risk Terms)
  • International Regulatory Requirements and Guidelines Overview
  • Regional Regulatory Requirements (FDA, EMA, Japan, China)
  • Post-marketing Surveillance and Safety Management
  • GVP - Pharmacovigilance Abbreviations
  • Advanced Review of Adverse Event Reporting

    Module 2 - Advanced Review of Pharmacovigilance:
  • Advanced Practice of Pharmacovigilance
  • Additional Encompassing and Confusing Terms in Pharmacovigilance
  • MedDRA (Hierarchy, Searching, Terms, Exporting, Assessing, Important Medical Events)
  • Need for Pharmacovigilance
  • The History of Pharmacovigilance
  • Roles in Pharmacovigilance
  • Key Stakeholders in Pharmacovigilance
  • Post-marketing AE Processing and Reporting (ICSR, Case Processing, Narrative Writing & International Aggregate Reporting)
  • Signal Management (Detection, Validation, Prioritization and Action)
  • Risk Assessment, Plan and Management
  • Vaccine Surveillance - COVID-19 Updated (AEFI, Vaccinology, AESI, AVSS, Communication and Case Studies)
  • Post-authorization/ Post-marketing Regulations in Pharmacovigilance

    Module 3 - Argus Safety Database Certification:
  • Argus Safety Database Certification Part 1 to Part 6

    Module 4 - Resources:
    A range of resources, guidelines, systems, addenda etc. is used in the course of training. Some of the ones relevant to the South African qualification are mentioned below.
  • ISoP Pharmacovigilance Resources
  • Pharmacovigilance Planning
  • Pharmacovigilance Systems
  • Post-authorisation Safety Studies
  • Pharmacovigilance Inspections
  • Risk Management Systems
  • Signal Management
  • Safety Communication
  • Risk Minimization Measures
  • Pharmacovigilance System Master File
  • Pharmacovigilance Audits
  • Periodic Safety Update Report

    Similarities:
    Module 1 - Fundamentals of Global Pharmacovigilance
  • Introduction to Drug Safety and PV
  • Key PV Terminology (Side Effect, Drug Safety and Risk Terms)
  • International Regulatory Requirements and Guidelines Overview
  • Post-marketing Surveillance and Safety Management
  • GVP - Pharmacovigilance Abbreviations
  • Advanced Review of Adverse Event Reporting

    Module 2 - Advanced Review of Pharmacovigilance
  • Advanced Practice of Pharmacovigilance
  • Additional Encompassing and Confusing Terms in Pharmacovigilance
  • Need for Pharmacovigilance
  • Roles in Pharmacovigilance
  • Key Stakeholders in Pharmacovigilance
  • Post-marketing AE Processing and Reporting (ICSR, Case Processing, Narrative Writing & International Aggregate Reporting)
  • Signal Management (Detection, Validation, Prioritization and Action)
  • Risk Assessment, Plan and Management
  • Post-authorization/ Post-marketing Regulations in Pharmacovigilance

    Differences:
  • Regional Regulatory Requirements (FDA, EMA, Japan, China) Module 2 - Advanced Review of Pharmacovigilance MedDRA (Hierarchy, Searching, Terms, Exporting, Assessing, Important Medical Events) The History of Pharmacovigilance Vaccine Surveillance - COVID-19 Updated (AEFI, Vaccinology, AESI, AVSS, Communication and Case Studies)
  • The other difference is that the South African qualification is a little longer than the US qualification.
  • On some aspects the US courses contain are more academically

    Conclusion:
    An analysis of the qualifications in these countries reveals a significant level of similarity between the South African qualification and those in the two identified countries. However, the courses offered in the United States cumulatively offer training in vigilance that is a little more comprehensive than the South African qualification. 
    		•

    ARTICULATION OPTIONS 
    This qualification provides opportunities for horizontal and vertical articulation options.

    Horizontal Articulation:
  • Occupational Certificate: Health Products Sales Representative, NQF Level 05.
  • Higher Certificate in Healthcare Management, NQF Level 05.

    Vertical Articulation:
    Occupational Certificate: Pharmacy Technician, NQF Level 06.

    Diagonal Articulation:
    National Certificate: Vocational: Primary Health, NQF Level 04. 
    		•

    MODERATION OPTIONS 
    N/A 

    CRITERIA FOR THE REGISTRATION OF ASSESSORS 
    N/A 

    NOTES 
    Qualifying for External Assessment:
    The Quality Partner is responsible for the management, conduct and implementation of the External Integrated Summative Assessment (EISA), in accordance with QCTO set standards. Competence in the EISA is a requirement for certificating a learner.

    For entrance into the EISA, the learner requires a valid Statement of Results issued by the accredited institution indicating:
    The attainment of all modules for the Knowledge, Practical and Work Experience modules.

    Additional Legal or Physical Entry Requirements:
  • None.

    Criteria for the accreditation of providers
    The curriculum title and code are: Health Products Vigilance Officer (HPVO): 242213-001-00-02.

    Encompassed Trade:
  • None.

    Assessment Quality Partner (AQP):
    Chemical Industries Education and training Authority (CHIETA)

    Associated Qualification(s)/Part-Qualification(s):
  • Occupational Certificate: Health Products Code Compliance Officer, NQF Level 5, 34 Credits.
  • Higher Occupational Certificate: Health Products Regulatory Assistant (HPRA), NQF Level 5, 134 Credits. 
    		•

    LEARNING PROGRAMMES RECORDED AGAINST THIS QUALIFICATION: 
     
    NONE 


    PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS QUALIFICATION: 
    This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.
     
    NONE 


    All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.