Chief Medicine Inspection Officer Grade 3
The Pharmacy and Medicines Regulatory Authority (PMRA) invites applications from suitably qualified, highly motivated and well experienced persons of Malawi origin to fill management positions tenable at the Pharmacy and Medicines Regulatory Authority Head Office in Lilongwe.
The Pharmacy and Medicines Regulatory Authority is a body corporate created by an Act of Parliament Number 9 of 2019 with the mandate to regulate medicines and allied substances, pharmaceutical businesses and pharmacy personnel and pharmacy training institutions in Malawi.
DETAILS OF THE POSITIONS
The details of the vacant positions are as follows:
Reporting to the Director General, the Chief Medicines Registration Officer will be responsible for overall management of pharmaceutical product quality assessment and safety surveillance activities. He/She will also oversee the training and licensing of pharmacy personnel to ensure delivery of quality pharmaceutical care. The prospective officer will head the Registration Department.
DUTIES AND RESPONSIBILITIES
i. Lead review process of pharmaceutical product dossiers to ensure an effective and efficient drug registration system and summarize findings for technical committee’s consideration;
ii. Co-ordinate Clinical Trial Protocol Review Process and summarize observations for the technical committee responsible for regulation of Clinical Trials;
iii. Implement a GCP inspections program for registered clinical trials to ensure protection of study subjects and generation of quality and credible results;
iv. Prepare short and long term strategies required for implementation of a functioning Pharmacovigilance system required to ascertain safety of pharmaceutical products on the market;
v. Facilitate development of competency standards for pharmaceutical training and ensure regulatory compliance to pharmaceutical practice standards;
vi. Ensure Liaison and close collaboration with key stakeholder agencies involved in enhancement of quality, safety, rational use, access, procurement, and supply of pharmaceutical products;
vii. Perform any other duties as may be required by the Director General.
QUALIFICATIONS AND EXPERIENCE
• Bachelor of Pharmacy Degree from a recognized University
• Must be a registered Pharmacist with the PMRA
• High degree of integrity and good conduct
• Post-graduate qualification in Pharmaceutical Quality or Safety related course would be an advantage.
• At least five years’ experience in a pharmaceutical regulation related field.
• Must be a self-starter and innovative
• Must have the technical knowledge and understanding of the pharmaceutical regulatory environment
• Possess excellent communications (both oral and written) and interpersonal skills
• Must have the ability to develop departmental plans and implement strategy for the Authority
• Must be able to lead a team of professionals towards the achievement of goals and objectives of the Authority and be part of the management team.
• Must be of high integrity and proven track record of achievement of results
• Must be fully conversant with the provisions of the PMRA Act number 9 of 2019.
• Must be fully computer literate in Microsoft packages.
• No criminal record.
METHOD OF APPLICATION
Interested individuals should submit their application with (i) with an up-to-date curriculum vitae(CV) with three traceable referees. At least one of whom should have been a first or second level supervisor of the applicant within the last 5 years; and (ii)certified true copies of their Academic and Professional Qualifications. The application should be sent to the address below: –
The Acting Director General
Pharmacy and Medicines Regulatory Authority.
Off Paul Kagame/Chilambula Road
PO. Box 30241
Or Electronic Submission:
Electronic submission of the application and accompanying materials to be mailed as attachments in PDF or MS Word format to email@example.com . The subject line of the application should indicate the Position(s) applied for.
Applications must reach the Director General of PMRA not later than Friday, 14th May 2021. Only shortlisted candidates will be acknowledged.