Medicines Control Officer (Reference NDOH 27/2013)

Advertiser: National Department of Health

Location: Pretoria

Salary: Grade 1: R399 480 - R443 364 per annum. A B-Pharm degree. No experience required. Grade 2: R463 611 -R514 539 per annum. Registration as a Pharmacist OR B-Pharm degree and a minimum of eight (8) years appropriate experience. Grade 3: R530 088 - R562 938 per annum. Registration as a Pharmacist and a minimum of eight (8) years appropriate experience OR A B-Pharm degree with a minimum of sixteen (16) years appropriate experience Salary grade will be determined in accordance with the above requirements as per the OSD. Originally certified certificates of service must be submitted with your application as well as proof of registration as a Pharmacist (where applicable).
Centre: Chief Directorate: Food Control, Pharmaceutical Trade and Product Regulation.
Directorate: Clinical Evaluation and Trials. Pretoria.

Requirements:
- Qualification and years of experience required are indicated above
- Knowledge and application of the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965) as amended and its related Regulations with respect to the regulation of medicines in terms of quality, safety and efficacy
- Good understanding of the conduct and control of clinical trials
- Knowledge of database management will be an advantage
- Computer skills
- Good planning, organisational, supervisory, report writing and presentation skills
- Good communication skills (written and verbal)
- High degree of dedication and accurate work
- Ability to work independently
- Must be willing to travel and work irregular hours
- A valid driver’s licence.

Duties:
- Review clinical trial applications and applicant responses
- Prepare committee and council documents
- Develop Standard Operating Procedures for conducting clinical trials as well as related policies and guidelines
- Technical screening and allocation of new clinical trial applications
- Review applications for additional sides, investigators and any other clinical trial correspondence
- Preparation of Clinical Trial Committee (CTC) and Medicine Control Council (MCC) documents and communicate resolutions to applicants
- Liaise with applicants and committee members
- Co-ordinate clinical trial activities and committee meetings
- Co-ordinate and keep records of clinical trial related activities
- Attend and minute CTC proceedings, execute recommendations and MCC resolutions
- Investigate pharmaceutical industry applicants’ queries and/or complaints
- Supervise administrative staff
- Perform other functions that may arise from time to time

Enquiries: Mrs P Nkambule tel (012) 395-8126 / 9470

The Department of Health is registered with the Department of Labour as a designated Employer and the filling of the following posts will be in line with the Employment Equity Act (including people with disabilities).

Applications:
The Director-General, National Department of Health, Private Bag X828, Pretoria. 0001. Hand delivered applications may be submitted at Reception (Brown application Box), Civitas Building, corner of Thabo Sehume (formerly known as Andries) and Struben streets, Pretoria.

For attention: Ms N Sombinge

Note:
Applications should be submitted on a Z83 form (click to download pdf form) and should be accompanied by a CV (previous experience must be comprehensively detailed) and certified copies of qualification certificates, service certificates, including ID and driver’s licence. No faxed or e-mailed applications will be considered. Applications received after the closing date and those that do not comply with the requirements will not be considered. It is the applicant’s responsibility to have foreign qualifications and national certificates (where applicable) evaluated by the South African Qualification Authority (SAQA). The department reserves the right not to fill the post. The successful candidate will be subjected to personnel suitability checks and other vetting procedures. Applicants are respectfully informed that correspondence will be limited to short-listed candidates only. If notification of an interview is not received within three (3) months after the closing date, candidates may regard their application as unsuccessful. The Department will not be liable where applicants use incorrect/no reference number(s) on their applications.

Reference number: NDOH 27/2013

Closing date: 6 May 2013