MEDICINE REGISTRATION OFFICER: PHARMACOVIGILANCE

To apply, click on the link at the end of the posts and all the best with your applications.

The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines
Regulatory Authority established in terms of the Medicines and Related Substances Act, 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: PHARMACOVIGILANCE (CONTRACT FOR 24-MONTHS)
SALARY: R700 105.00 – R888 422.00 per annum (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market-related salary will be determined by the years of experience obtained
post qualification, Internship and Community Service in line with governing frameworks.

Ref No.: SAHPRA 12/2025
CENTRE: PRETORIA

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.

COMPETENCIES, KNOWLEDGE, AND SKILLS: 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. Basic knowledge of the medicines regulatory
framework, policies, and process. Knowledge and understanding of clinical pharmacology. Basic
understanding of medicine registration and harmonisation.

• Excellent interpersonal and communication skills (written and verbal)
• Critical thinking
• Ability to exercise good judgment and solve problems quickly and effectively
• Computer skills
• Solution orientated
• Ability to work under pressure
• Ability to maintain high levels of confidentiality
• Interpersonal skills
• Change management
• Knowledge management
• Service delivery innovation
• Problem-solving and analysis
• Client orientation and customer focus
• Proactive stakeholder management
• Situational adaptability
• Collaboration

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 ofserious 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).

INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):

• Interested persons who meet the above-stated requirements should submit their application,
  clearly state the position name and post reference number, including a signed cover letter,
  clearly state the position name and post reference number, detailed Curriculum Vitae (CV)
  with the names and email addresses of three (3) referees, copies of required qualifications
  (including matric) and Identity Document. ONLY shortlisted candidates will be required to
  submit certified copies of qualifications and other related documents on or before the day of
  the interview following communication from Human Resources.
• Should you be in a possession of foreign qualification, your application must be accompanied
  by an evaluation certificate (report) from the South African Qualifications Authority (SAQA).
• Incomplete applications or applications without the aforementioned documents or
  information will not be considered.
• No late applications will be accepted. Any submissions received after the specified date and
  time will not be considered, and CVs will not be returned.
• Due to the larger number of responses anticipated, communication will be limited to shortlisted candidates only. Applicants who have not been contacted within three (3) months after
  the closing date should consider their application was unsuccessful.
• Shortlisted candidates will be expected to attend selection interviews at a date, time, and
  location as specified by SAHPRA.
• Applicants should note that that pre-suitability checks will be conducted after they have been
  shortlisted. Their appointment is subject to positive outcomes from these checks, which
  include security clearance, verification of qualifications, criminal records, credit checks,
  citizenship status, and work experience.
• SAHPRA is committed to being an equal opportunity employer. When filling vacant positions,
  the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the
  Republic of South Africa, Act 101 of 1996, and the Employment Equity Act, 55 of 1998.
  Applicants with disabilities are encouraged to apply and indicate their disability status, which
  will be appreciated.
• SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
• SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of

1. CVs will not be returned, as personal information you provide will be used solely for
   recruitment purposes, specifically for the position or vacancy you have applied for. If your
   application is unsuccessful, your personal information will be retained for internal audit
   purposes.

• Applications should be submitted through the SAHPRA Website Online Portal: SAHPRA
  website (https://www.sahpra.org.za) – About Us – Vacancies.
• For enquiries: Please contact Ms Bafedile Rakgotho, HR Business Partner, via email at
  bafedile.rakgotho@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL
  ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.
• The closing date is 19 March 2025 at 16:00.

Click here to apply

We wish you all the best with your applications