- Published on
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY
CALL FOR EXPRESSION OF INTEREST
EXTERNAL EVALUATORS
The South African Health Products Regulatory Authority (SAHPRA) hereby invite expression of interest for candidates to serve as External Evaluators for Quality and Bioequivalence.
SAHPRA is a Schedule 3A Public Entity established in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) to oversee the regulation of medicines, medical devices, and in vitro diagnostics (IVDs) intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices and IVDs; and the conduct of clinical trials.
REQUIREMENTS
The External Evaluators are appointed in terms of section 3 (5) of the Medicine’s Act, as amended to assist the Authority in carrying out its functions. These fully qualified external evaluators are crucial to supplementing the skills and experience of the Authority in the area of Quality and Bioequivalence study.
Expression of interest is required for experts who are already familiar with the ICH guidelines, SAHPRA and SADC guidelines as well as eCTD dossier reviews for both new registrations and variations such that they are able to commence with immediate effect.
Reviewers who have review experience in National regulatory authorities (minimum 3 years of primary review and peer review), who are assessors on various regional economic communities (REC’s) such as Zazibona (SADC) etc and have experience with organisational reviews such as WHO PQ would have added advantage for consideration.
Exclusions:
- Where such person is conflicted in terms of SAHPRA Policy on Management of Conflict of Interest (GOV02);
- is disqualified under the Relevant Act applicable to his or her profession from practising as such;
- has been found guilty of improper or disgraceful conduct at an inquiry held under ambit of the relevant Act;
- is a patient as defined in section 1 of the Mental Health Care Act, 2002 (Act No. 17 of 2002);
- has been convicted of an offence in respect whereof he or she was sentenced to imprisonment without the option of a fine or in the case of fraud;
- does not meet the minimum requirements;
Relevant Qualifications: Appropriate degree in medicine pharmacy/pharmaceutical sciences, and relevant sciences.
CALL FOR EXPRESSION OF INTEREST
EXTERNAL EVALUATORS
The South African Health Products Regulatory Authority (SAHPRA) hereby invite expression of interest for candidates to serve as External Evaluators for Quality and Bioequivalence.
SAHPRA is a Schedule 3A Public Entity established in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) to oversee the regulation of medicines, medical devices, and in vitro diagnostics (IVDs) intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices and IVDs; and the conduct of clinical trials.
REQUIREMENTS
The External Evaluators are appointed in terms of section 3 (5) of the Medicine’s Act, as amended to assist the Authority in carrying out its functions. These fully qualified external evaluators are crucial to supplementing the skills and experience of the Authority in the area of Quality and Bioequivalence study.
Expression of interest is required for experts who are already familiar with the ICH guidelines, SAHPRA and SADC guidelines as well as eCTD dossier reviews for both new registrations and variations such that they are able to commence with immediate effect.
Reviewers who have review experience in National regulatory authorities (minimum 3 years of primary review and peer review), who are assessors on various regional economic communities (REC’s) such as Zazibona (SADC) etc and have experience with organisational reviews such as WHO PQ would have added advantage for consideration.
Exclusions:
- Where such person is conflicted in terms of SAHPRA Policy on Management of Conflict of Interest (GOV02);
- is disqualified under the Relevant Act applicable to his or her profession from practising as such;
- has been found guilty of improper or disgraceful conduct at an inquiry held under ambit of the relevant Act;
- is a patient as defined in section 1 of the Mental Health Care Act, 2002 (Act No. 17 of 2002);
- has been convicted of an offence in respect whereof he or she was sentenced to imprisonment without the option of a fine or in the case of fraud;
- does not meet the minimum requirements;
Relevant Qualifications: Appropriate degree in medicine pharmacy/pharmaceutical sciences, and relevant sciences.
TERM OF OFFICE
The term of service for external evaluators is three (3) years effective from date of appointment and may be appointed for a further extension of term(s).
PROCEDURE
• A comprehensive CV, qualification/s and a motivation expressing interest and area of review experience with relevant supportive documents must be submitted online at https://apply.sahpra.org.za:6006
• Only documents in pdf must be uploaded.
• Further communication will be limited to nominated candidates with appropriate skill sets.
• Closing date for nominations is Friday, 26 April 2024 at 16h30. No late nominations will be accepted.
Enquiries: Ms Mukona Mphidi at mukona.mphidi@sahpra.org.za