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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) - PORTFOLIO COORDINATOR: VARIATIONS
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
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.
PORTFOLIO COORDINATOR: VARIATIONS
DPSA Equivalent Level SR 11 (Non OSD)
(Full-time 12 Months Fixed term Contract)
Ref No.: SAHPRA 024/2021
NB. Re-Advertisement: Candidates who previously applied and are still interested need to re-apply
CENTRE: Pretoria
REQUIREMENTS: Relevant Bachelor’s degree in Pharmacy or Natural Sciences (NQF Level 7) plus Certificate in Project Management and at least Five (5) years of relevant experience. Experience in the Medicines Regulatory environment as well as Risk and Software management would be an advantage.
COMPETENCIES/SKILLS: * Strong administrative and organizational skills. * Willingness to work extended hours as and when required. * Ability to communicate at all levels. * Deadline driven. * Attention to details. * Versatility and Innovative thinking. * Team player and can work independently. * Ability to work well under pressure.
DUTIES:
• Manages the variation and response application process, ensuring that timeframes and quality standards are maintained.
• Manages the progress of variation and response applications against established timeframes and milestones to ensure that approvals are achieved within the timelines stipulated in the Variations Addendum.
• Maintains the accessibility, quality, and accuracy of information on the tracker and Shared drive.
• Manages preparations for Advisory Committee meetings to facilitate the finalization of regulatory decisions.
• Responsible for collating information and presenting quarterly performance reports.
REQUIREMENTS: Relevant Bachelor’s degree in Pharmacy or Natural Sciences (NQF Level 7) plus Certificate in Project Management and at least Five (5) years of relevant experience. Experience in the Medicines Regulatory environment as well as Risk and Software management would be an advantage.
COMPETENCIES/SKILLS: * Strong administrative and organizational skills. * Willingness to work extended hours as and when required. * Ability to communicate at all levels. * Deadline driven. * Attention to details. * Versatility and Innovative thinking. * Team player and can work independently. * Ability to work well under pressure.
DUTIES:
• Manages the variation and response application process, ensuring that timeframes and quality standards are maintained.
• Manages the progress of variation and response applications against established timeframes and milestones to ensure that approvals are achieved within the timelines stipulated in the Variations Addendum.
• Maintains the accessibility, quality, and accuracy of information on the tracker and Shared drive.
• Manages preparations for Advisory Committee meetings to facilitate the finalization of regulatory decisions.
• Responsible for collating information and presenting quarterly performance reports.
• 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 recruitment@sahpra.org.za including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s 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.
INSTRUCTIONS TO APPLICANTS: All applications must:
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: Email: matshepo.mokotong@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 27 September 2021 at 16H00.