ZAMBIA MEDICINES REGULATORY AUTHORITY EMPLOYMENT OPPORTUNITY

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1 ZAMBIA MEDICINES REGULATORY AUTHORITY EMPLOYMENT OPPORTUNITY The Zambia Medicines Regulatory Authority (ZAMRA) was set up by the Medicines and Allied Substances Act (No. 3) of 2013 as a statutory body responsible for medicine and allied substances regulation in Zambia. The Zambia Medicines Regulatory Authority invites applications from suitably qualified Zambian citizens to fill the following vacant positions at the Zambia Medicines Regulatory Authority: 1. INSPECTOR GDP & ACCESS (4) To undertake the inspection of distribution channels of medicines and allied substances such as hospital pharmacies and wholesale dealing of medicines and allied and certain health facilities in order to promote access to medicines and allied substances; achieve compliance to set standards and adherence to licensing terms and conditions. BSc degree in Pharmacy No prior experience is required for this position. Recent graduates are encouraged Supervises and undertakes timely, inspection pharmaceutical establishments in order to ensure compliance and adherence to licensing terms and conditions. Supervises and undertakes timely and effectively, product sampling screening in order to facilitate product testing and sample evaluation. Undertakes timely, data entry of inspection reports and schedule into the database in order to facilitate decision-making.

2 Undertakes timely, data entry of inspection reports and schedule into the database in order to facilitate decision-making. Supervises effectively, staff in order to ensure the attainment of the department s objectives. 2. SURVEILLANCE OFFICER DRUG INFORMATION (1) To undertake the monitoring of labeling information, advertisements and promotion of medicines and allied substances in order to ensure the safety and efficacy of medicines and allied substances. BSc degree in Pharmacy/Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes the timely, review of application for advertising and promoting of medicines and allied substances in order to conform to marketing authorisation terms. Undertakes effectively, the investigations of reports on quality and labeling of medicines and allied substances in order to conform to marketing authorisation terms and product specification. Undertakes timely and effectively, the recall of medicines and allied substances in order to ensure products not meeting requirements are removed from the market. Timely and effectively supports, the product sampling and screening in order to facilitate product testing and sample evaluation. Undertakes effectively, the labeling, storage and retrieval of samples in order to ensure integrity and chain of custody Undertakes effectively, the entry of data on to the database in order to ensure accurate reporting.

3 3. SURVEILLANCE OFFICER - PHARMACOVIGILANCE (1) To undertake the monitoring of adverse reactions and events in order to ensure compliance to set standards and guidelines. BSc degree in Pharmacy/ Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes timely, assessment of adverse drug reaction reports in order to ascertain causality and recommend appropriate intervention. Undertakes effectively, the gathering and dissemination of drug information in order to promote rational use of medicines and allied substances. Undertakes effectively, the development and dissemination of IEC materials in order to promote public awareness. Undertakes effectively, the entry of data on to the database in order to ensure accurate reporting. 4. INSPECTOR - GMP (1) To undertake the inspection of premises for manufacture of medicines and allied substances in order to achieve compliance to set standards and adherence to licensing terms and conditions. BSc degree in Pharmacy /Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes timely and effectively, GMP inspections of premises for manufacture of medicines & allied substances in order to achieve compliance. Undertakes timely and effectively, product sampling screening in order to facilitate product testing and sample evaluation. Undertakes timely, data entry of inspection reports and schedule into the database in order to facilitate decision making

4 5. INSPECTOR - INVESTIGATIONS (2) To undertake the enforcement of the law relating to medicines and allied substances in order to discover and punish persons who violate or contravene it. BSc degree in Pharmacy/Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes effectively, the gathering of information relating to medicines and allied substances in order to facilitate possible investigations. Undertakes effectively, the investigations relating to medicines and allied substances in order to facilitate decision-making. Undertakes effectively, the prosecution of cases relating to medicines and allied substances in order to punish persons who violate or contravene Medicines and Allied Substances Act No. 3 of 2013 and other related statutes. Performs timely, data entry of investigations and cases into the database in order to ensure accurate capturing of information. 6. LICENSING OFFICER (1) To undertake registration of Biotech products in order to achieve compliance to set To supervise and undertake the processing of licences, permits and certificates for premises and authorisation to import and export medicines and allied substances, in order to facilitate their issuance. BSc degree in Pharmacy/Equivalent No prior experience is required for this position. Recent graduates are encouraged

5 Undertakes effectively, the processing of licences and permits for narcotic drugs, psychotropic substances and precursors in a timely manner in order to facilitate their issuance. Undertakes effectively, the handling of annual returns, transfers and amendments of licences, certificates and permits in order to facilitate compliance to the terms and conditions of licensing. Undertakes timely, the development and review of schedules for monitoring activities in order to prevent misuses and abuse of narcotic drugs, psychotropic substances and precursors. Undertakes and aggregates timely, annual requirements for narcotic drugs, psychotropic substances and precursors in order to ensure prompt reporting to the International Narcotics Control Board (INCB) and facilitation of trade. Undertakes timely, the maintenance of registers in order to have up to date information. Undertakes timely, data entry in order to facilitate decision-making. 7. REGISTRATION OFFICER - BIOTECH PRODUCTS (1) To undertake registration of Biotech products in order to achieve compliance to set BSc degree in Biochemistry/Biomedicine/Molecular Biology/ /Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes effectively, the registration of Biotech products for human use in order to authorize their use. Undertakes effectively, the maintenance of the Biotech products information management system in order to facilitate storage, processing, retrieval and dissemination of information Undertakes effectively the screening of applications for registration of medical devices in order to ascertain their completeness and validity Undertakes effectively the receipting, acknowledgement and inputting of information on applications in order to facilitate processing

6 8. REGISTRATION OFFICER - MEDICAL DEVICES (1) To undertake registration of medical devices in order to achieve compliance to set BSc degree in Biomedical Sciences/Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes effectively, the registration of Medical Devices for human and animal use in order to achieve compliance to set standards. Undertakes effectively, the maintenance of the medical devices information management system in order to facilitate storage, processing, retrieval and dissemination of information Undertakes effectively the screening of applications for registration of medical devices in order to ascertain their completeness and validity Undertakes effectively the receipting, acknowledgement and inputting of information on applications in order to facilitate processing 9. REGISTRATION OFFICER - ALLIED SUBSTANCES (1) To undertake registration of allied substances in order to achieve compliance to set BSc degree in Pharmacy/Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertake and undertakes effectively, the registration of allied substances for human and animal use in order to achieve compliance to set standards.

7 Undertake effectively, the registration of medical devices for human and animal use in order to achieve compliance to set standards. Undertakes regularly, the development, review and dissemination of market authorisation guidelines in order to inform potential applicants and staff. Undertakes and undertakes effectively, the maintenance of the allied substances information management system in order to facilitate storage, processing, retrieval and dissemination of information Undertakes effectively the implementation of performance management systems in order to facilitate improvement in performance and productivity. ZAMRA is an Equal opportunity employer with good package for successful candidate. Interested Zambian citizens should send applications with detailed Curriculum Vitae that includes , fax, telephone / cell phone numbers and certified copies of original certificates with three (03) traceable references to:- The Director General Zambia Medicines Regulatory Authority Plot No.6903 Tuleteka Road, Off Makishi Road P O Box LUSAKA Closing date: 2 nd February 2018 Please note that only short-listed candidates will be notified.

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