25 May MEDICINE REGISTRATION OFFICER: VIGILANCE GR 3 X2
Ref No.: SAHPRA 019/2021
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 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.
- Appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with the South African Pharmacy Council (SAPC).
- Knowledge of technical evaluation of safety and efficacy aspects of medicines.
- A minimum of 8 years’ appropriate experience.
- Knowledge and application of the Medicines and Related Substances Control Act 101 of 1965, as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy.
- Computer literacy (MS Office packages).
- Supervisory skills.
- Good planning, organisational and interpersonal skills/qualities.
- Good communication skills (written and verbal).
- Innovative thinking, initiative, and leadership qualities.
- Dedication and accurate work.
- Knowledge of database management will be advantageous.
- Must be willing to travel and work irregular hours.
- Collection, management and assessment of suspected Adverse Drug Reactions:
- Technical screening of ADR reports.
- Critically evaluate the reports before committing reports to the VigiBase.
- Conduct causality assessment of serious cases and cases of interest.
- Perform signal detection and conduct investigations.
- Prepare review report for discussions at Pharmacovigilance Advisory Committee.
- Partnerships, Collaboration & Communication:
- Prepare and attend Industry engagements and other Regulatory Forums.
- Respond to queries timeously. * Keep abreast of the latest safety concerns.
- Prepare and facilitate the review and finalisation of press release, medicine safety alert, dear healthcare professional letters and Vigilance Newsletter.
- Preparation of meeting documents for the peer- review/Pharmacovigilance Advisory Committees:
- Investigate safe concerns and prepare review report for peer-review.
- Peer-review reports done by other reviewers.
- Capturing the Pharmacovigilance Advisory Committee minutes and recommendations.
- Execute Pharmacovigilance Advisory Committee recommendations and communicate within 5 working days.
- Vigilance awareness, promotion and training:
- Awareness and promotion of vigilance among HCPs and the public.
- Training of HCPs and students on vigilance scope.
- Development of vigilance training material.
- Presentation and exhibitions at medical and pharmaceutical conferences.
INSTRUCTIONS TO APPLICANTS: All applications must:
- Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.
- Applications without the afore mentioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
- A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
- Applications must be submitted by email to firstname.lastname@example.org, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
- No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered.
- Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
- It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo
- Email: email@example.com (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).