Requirements 

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). A relevant Master’s qualification at NQF level 9 as recognised by SAQA will be an added advantage. Valid driver’s license. 

Experience 

• Grade 1: Four-year Bachelor of Pharmacy degree and registration as a Pharmacist with the SAPC at NQF level 8 as recognised by SAQA plus a minimum of three (3) years’ experience as a practising pharmacist post community service, of which two (2) should be in pharmaceutical regulatory environment.
• Grade 2: Four-year Bachelor of Pharmacy degree and registration as a Pharmacist the SAPC at NQF level 8 as recognised by SAQA plus a minimum of five (5) years’ experience as a practising pharmacist post community service, of which three (3) should be in pharmaceutical regulatory environment. 

Competencies, Knowledge and Skills 

*A solid understanding of application procedures. *Medicines Act as Amended and its Regulations. *Consolidated Schedules. *Planning and organisational skills. *Interpersonal skills. *Investigation skills. *Computer skills and knowledge of MS Office. *Drive and self-management skills. *Communication skills. *Report writing. *Resilience. *Assertiveness. *Ethical behaviour. *Ability to work under pressure and irregular hours. *Professionalism. *Ethical conduct and adherence to the SAHPRA Code of Conduct. *Integrity. 

Duties 

Investigation of compliance / non-compliance and reporting: Investigate matters related to the contravention of the Medicines Act (medical device establishments, pharmacies, complementary medicine establishments, ports of entry, illegal establishments, etc. Investigate complaints relating to the advertising of medicines (control of promotional, marketing, and advertising activities). Allocated post-marketing surveillance of advertising cases. Issuing of authorisations for samples, reference standards, etc relating to import, export. Processing of applications for donations. Processing of applications for Section 36. Coordinate, review applications for destruction of scheduled medicines/substances, medical devices, and IVDs. Cooperation and collaborations with stakeholders locally and abroad. Review applications and compile possession permits for manufacturing and research. Detention/seizure of non-compliant products. Coordinate and schedule allocated investigations with the team inspector as per allocation. Investigate and attend to industry /applicant queries. Conduct joint inspection/s with law enforcement agencies (e.g. BMA, SARS, HPCSA, SAVC, SAPS & SAPC). Perform all activities according to relevant SOPs. Responsible for overall Product Quality defects/ Complaints activities requiring Alerts and Recalls actions (Substandard/Falsified medical products): Identify activities relating to Product Quality defects, specifically those requiring alerts. Apply the SOP for alerts/recalls timely. Ensure that management is updated. Ensure that appropriate communication is prepared for approval. Ensure that draft information for internal and external stakeholders is available for review and approval. Ensure that Applicants comply with the conditions of alerts/recalls. Update the website notifications. Prepare a monthly report for the manager. Write an annual report for alerts/recalls. Provide feedback to relevant SAHPRA unit/s where applicable. Inspection and reporting: Inspect allocated sites (e.g. Cannabis sites, pharmacies, wholesalers – site can be based on the complaint received). Reports to be completed within 30 working days from the inspection date. Help review the SOP for Investigations and conduct inspections in accordance with SOP. Participate in risk and audit enquiries (internal and external audits). Compile reports and resolutions for the Licensing Unit or referral unit applicable. Ensure the reports comply with QMS approved formats. Lodge criminal cases with the authorities and appear in court when subpoenaed: Where criminal offenses are identified, open criminal cases with the South African Police Services (SAPS) and write affidavits/statements. Attend to court as per subpoena. Assist SAPS/National Prosecuting Authority with writing affidavits for crimes relating to contravention of the Medicines Act. Strengthen Cooperation with stakeholders (training, information sharing): Participate in Border Management Authority, South African Revenue Services, SAPS, Health Professions Council for South Africa and SAPC as aligned with Memoranda of Understanding (MoUs). Attend meetings, conferences and briefings with stakeholders, including workshops and training overseas. Support the initiatives of stakeholders which are relating to contravention of the Medicines Act. Support the Communication Unit’s queries relating to media. Training of stakeholders. Consult with internal core business and support units whenever applicable (Manager, Senior Manager, Executive Management, Advisory Committees, Complementary Medicines, Medical Device Unit, Section 21, Names and Scheduling, Veterinary, Biological). Foster cooperation and collaboration with relevant SAHPRA units to enhance appropriate regulatory outcomes on matters. Foster cooperation and collaboration with statutory bodies, industry associations, activist organisations and media. Attend operations quarterly with law enforcement agencies. Reporting: Participate in risk and audit queries relating to your focal area. Submit and present performance reports on your focal area monthly. Comply with QMS requirements for a clean audit. Review SOP and Guidelines for alerts, recalls and withdrawals as required.