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ROYAL GOVERNMENT OF BHUTAN ROYAL CIVIL SERVICE COMMISSION POSITION DESCRIPTION 1. JOB IDENTIFICATION: 1.1 Position Title: Drug Controller 1.2 Position level: P1 1.2 Major Group: Medical Services Group 1.3 Sub Group: Pharmaceutical Services 1.4 Job Code No.: 15-690-05 1.5 Job Location (Complete as appropriate): Ministry: _____MoH_____; Department: __DRA_____, Division: __DRA___; Section: ____________; Unit: __________________. 1.6 Title of First Level Supervisor: (Official title of Supervisor). Bhutan Medicines Board 2. DUTIES AND RESPONSIBILITIES: Describe the main duties and responsibilities, indicating what is done and how it is done. Duties should be presented in decreasing order of percentage of time spent on them, or in order of relative importance. Purpose: To safeguard the Human and Animal Health against harm resulting from poor quality, Spurious or adulterated or counterfeit drugs and medicines. To control and regulate manufacture, sales, import, export, distribution of medicinal products. Prepare and formulate policies and plans to protect and safe guard citizens simultaneously enhance economic growth. SL. Duties and Responsibilities % Time No 1. i. Prepare and formulate policies and plans on regulations and control 60 measures. Develop control and regulatory strategies related to drugs and vaccines. Set vision for the authority and prepare both long and short term plans. Liaise with Pharmaceutical Companies from abroad on registration and import/export matters. Conducts studies and generate reports on drugs and related issues for the Ministries to consider as national policy. ii. Develop documents required for registration of medicinal; products including veterinary in the Kingdom. Supervise scrutiny of documents for registration and approve registration of drugs and medicinal products. iii. Develop protocols and standard operating procedures for drug inspectors and supervise inspectors. iv. Approve Good Laboratory Practices developed by Drug Testing Laboratory and get samples of drugs tested to assure safety, quality and efficacy. v. Liaise with Appellate Laboratory, Courts, Revenue and Customs, Trade and Industry, local shop and police on regulatory and enforcement matters. vi. Be the Chairperson of the registration Committee, member Secretary to the Bhutan Medicine Board. Authorization for manufacture, import, export, sale, distribution of medicinal products in the country. Ensure control of the prices of the medicinal products. Award technical authorization for competent persons. vii. Supervise, control and motivate sub-ordinates working as registrars, Drug Inspectors and Government Analyst. viii. Advise Government on issues related to drugs and their control. ix. Assess the training needs, promotion and location / relocation of the staff to carry out the functions of Authority effectively and efficiently. 2. Work, interact and liaise with other relevant departments or agencies at both 20 intra-ministerial and inter-ministerial agencies to raise, negotiate and justify issues that are important and significant at the national level. Then prepare programs and guidelines and propose necessary changes in the Bhutan Medicine Act 2003 and Bhutan Medicine Rules and Regulation 2005. 3. Liaise with internal agencies such as UNODC (United Nations Office on 15 Drugs and Crime), INCB (International Narcotic Control Board), UNDCP (United Nations Drug Control Programme) and WHO on matter related to drugs as a national Competent Authority and submit periodic report as a part of fulfillment to the UN conventions of 1961, 1971 and 1988. Representing the country in forums and put forward issues of national interest and involve in negotiation of issues that are important both for the National and international level. 4. Train Health personnel, DRA staff and public on various issues related to 3 regulation, inspection, and registration of drugs. 5 Attend the seminars, workshop both at international, regional and national level and add programs or make necessary changes in the programs for 2 implementation as per the outcomes, recommendations and resolutions of such seminars and workshops to strengthen DRA. 3. KNOWLEDGE & SKILLS REQUIREMENTS: Minimum requirement for performance of work described (Level of Knowledge, Skill and Ability). 3.1 Education: Masters degree in the relevant field of study with working experience of 5 years in the Pharmaceutical industries or relevant field. 3.2 Training: He/She should have undergone training in regulations and medicines acts. 3.3 Length and type of practical experience required: Minimum of 4 years of experience in various fields of regulations and Pharmaceutical industries or relevant field of pharmaceutics as Dy. Drug Controller or equivalent experience. The person should have sound knowledge on regulations of medicinal products both at national and international levels. He/she should have sound knowledge on the principles of planning and programming applied to the government program and demonstrated extraordinary skills in giving strategic direction to the Authority. He/she should have strong ability to take quick and relevant decisions on complex issues. Skills and experiences to liaise with international organizations, central programs and other agencies both within and outside the Kingdom to justify and negotiate issues that are significant and are of national importance OR equivalent experience. 3.4 Knowledge of language(s) and other specialized requirements: Person should have good sense of leadership and integrity. The person should have a good command of speaking, reading and writing in English and Dzongkha. The person should have skills for writing high quality scientific papers and provide advisory support and guidance to the head of the agency as well as to the subordinate staff. Ability to express ideas clearly and concisely both orally and in writing to a wide range of audience. The person should have sound knowledge on international conventions and treaties, national laws and understand their sensitivities. Good working knowledge of computer application. 4. COMPLEXITY OF WORK. Describe the intricacy of tasks, steps process or methods involved in work, difficulty and originality involved in work. The work demands a highest-level professional knowledge related to the drugs, vaccines and medicinal products. It would also require vast administrative knowledge and experience pertaining to the enforcement of the regulation. Work requires extensive in-depth analysis in identifying problems, carrying out analysis of reports, taking important decisions, preparing plans and programs, defining and changing the course of works as per the findings and needs of the government policies and plans. He/she should take the main roles and responsibilities in strengthening and take the Authority forward. The work would also require providing recommendations and initiating necessary changes in the acts, rules and regulations and latest trends in drugs and Pharmaceutics. 5. SCOPE AND EFFECT OF WORK: Describe the purpose, breadth of work performance, and the effect the work has on the work of others or the functions of the organization. The work carried out by him/her is very important as it involves preparation and formulation of plans and policies at national level concerning the safety of drugs both for human and animal health. The implementation of the Bhutan Medicines Act and Regulation has a very significant bearing on ensuring safety, quality and efficacy of drugs and protect the citizens from the risk of spurious and adulterated drug. Also minimize resistance to antibiotics by regulating its import, distribution and sales thus reducing the overall cost on Health Services. Regulate and control the use and abuse of Narcotic Drugs and Psychotropic Substances in the kingdom. The work also relates to fulfilling Kingdom’s obligation towards international conventions such UN Single Convention on Narcotic Drugs 1961, Convention on Psychotropic Substances 1971 and UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1998. The work of enforcement of law requires liaising with other agencies both government and non government and private sector demands tactful handling of situation and issues. There is need to send the reports to various international agencies as a part of obligation. Interact with such agencies on the behalf of the government and present the case and accord financial support. 6. INSTRUCTIONS AND GUIDELINES AVAILABLE: 6.1 Instructions: Describe controls exercised over the work by the Superior; how work is assigned, reviewed and evaluated. Instructions and guidelines available in terms of broadly defined missions and functions in the Bhutan Medicines Act 2003, Bhutan Medicine Rules and Regulation, Narcotic Drugs, Psychotropic Substances and Substances Abuse Act 2005 and international Convention on specific matters. The broad guidelines and instructions are also given by the board. 6.2 Guidelines: Indicate which written or unwritten guidelines are available, and the extent to which the employees may interpret, adapt or devise new guidelines. Over all frame work is covered by the Bhutan Medicine Act 2003. The plans, programs, designs and guidelines prepared by him/her more or less independently under the broad instructions and guidelines that are applicable to Bhutanese situation and the necessary amendments in the acts he/she recommends would be mostly accepted as technical matter. 7. WORK RELATIONSHIPS: Indicate the frequency, nature and purpose of contacts with others within and outside the assigned organization (other than contacts with superiors): He/she should also maintain constant touch and interact constantly on behalf of Authority with the concerned officials and offices of international organizations such as UNODC (United Nations Office on Drugs and Crime), INCB (International Narcotic Control Board), UNDCP (United Nations Drug Control Programme) and WHO on matter related to drugs as a national Competent Authority and submit periodic report as a part of fulfillment to the UN conventions. He is closely with Ministry of trade and Industries, Ministry of Finance, Ministry of Agriculture, Royal Bhutan Police, Legal bodies and private sectors. 8 SUPERVISION OVER OTHERS: Describe responsibility for supervision of other employees, including the nature of supervisory responsibilities and categories and number of subordinates. Provided directions, coordination and supervision, monitoring and evaluation DRA staff and provide professional leadership and motivate to produce results and achieve goals. 9. JOB ENVIRONMENT: Describe physical exertion required, such as walking, standing, lifting heavy objects, etc., and/or any risks or discomforts like exposure to hazards such as exposure to chemicals, infections, radiation, extreme weather and other hostile working conditions. He is mainly based at the head quarters with occasional travel to field units for physical and technical verification and monitoring the works carried out by the field staff. Most often work will demand extra-working works wherein much mental efforts needs to be put in emergency situations for giving the new direction and instructions to subordinates. Such works would demand long working hours and mental exertion.
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