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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) - PORTFOLIO COORDINATOR
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
Ref No.: SAHPRA 012/2020
CENTRE: Pretoria
REQUIREMENTS: Appropriate 4-year Bachelor of Pharmacy Degree or BSc in a Biological Science or equivalent. Registration with SAPC or HPCSA. Proven experience: * Grade 2: Chemistry degree - 10 years, B Pharm Degree - 8 years, Registration as Pharmacist - none. * Grade 3: Chemistry Degree - 18 years, B Pharm degree – 16 years, Registration as a Pharmacist - 8 years
KNOWLEDGE AND SKILLS: *Sound working knowledge of document management and workflow management software. *Comfort working with computers and computer software packages. *Technical knowledge of the regulatory environment is an added bonus. *Knowledge of CTD and eCTD software applications is an added bonus. *Display exceptional stakeholder management capabilities. *Ability to communicate fluently in English with both written and verbal communication. *Defines and prioritizes goals in the face demands to keep people focused on achieving business objectives. *Good leadership and decision-making ability. *Critical thinking and problem-solving skills. *Planning and coordination skills. *Ability to manage conflict. *Ability to tolerate stress.
DUTIES:
Build and maintain relationships with applicants through constant communication: *Act as the primary point of contact for applicants, facilitating technical conversations with evaluators when deemed necessary. *Capture details of application on system once allocated and update application status as it advances through the process. *Consolidate queries and relay those to the applicant, communicate all subsequent responses to the evaluators. *Consistently update applicants on the status of their applications as they advance through the process. This includes notifying applicants should their application be rejected by any division. *Develop a finalised report for approved application by compiling all approval report summaries.
Facilitate the allocation of applications: *Develop a work-plan schedule that is in line with the backlog clearance strategy and use it to select the applications that are next in the queue to be evaluated and processed. *Inform evaluator coordinators of the application type, skills required and expected time. *Ensure all applications requiring a division’s external committee review are forwarded to the relevant committee and reviewed at the next committee meeting. *Receive committee recommendations should any department’s committee be required to make final judgement on an application. *Follow up on outstanding recommendations. *Pass on recommendations to staff responsible for registration document preparation.
Track and convey status to applicants: *Relay end to end schedule of applications to industry, as well as current status.
INSTRUCTIONS TO APPLICANTS: All applications must:
Be made on Z83 forms (obtainable http://www.dpsa.gov.za/dpsa2g/documents/forms/employ.pdf or from any Government department).
Be completed in full, clearly reflect the name of the position, name and date of the publication (candidates must use the post reference numbers), 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 form 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.
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, Tel: +27 71 605 1508.
Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 11 May 2020 at 16H00.