General Director of AMDM - Dragoș GUȚU

Deputy General Director - Lina GUDIMA

1. Organizes and coordinates the process of expertise and authorization of medications, implements and develops the pharmacovigilance system, approves and supervises the conduct of clinical trials; monitors the rational use of medications.
2. Supervises the quality of domestic and imported medications and conducts expertise of the analytical and normative documentation submitted for medication registration in the Republic of Moldova.
3. Verifies and monitors pharmaceutical activities carried out within pharmaceutical enterprises and institutions; verifies the implementation and compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Good Pharmacy Practice (GPP) rules.
4. Applies surveillance procedures for medications and medical devices placed on the pharmaceutical market of the Republic of Moldova, including the authorization of their import.
5. Provides informational and methodological assistance to pharmaceutical enterprises, institutions, and economic agents.
6. Evaluates the set of documents submitted for the registration of the manufacturer's price for medications and manages the National Price Catalog, in accordance with Law No. 71-XV of March 22, 2007 on registers.

1. In the field of medication authorization: organizes and monitors the expertise, approval, and registration of medications; issues and approves registration certificates for medications to applicants; decides on the suspension or withdrawal of medication registration certificates, following the procedure established by Law No. 235-XVI of July 20, 2006 on the basic principles of regulating entrepreneurial activity.
2. In the field of evaluation, expertise, and quality monitoring of medications: conducts quality control of domestic and imported medications; takes measures to prevent the introduction of medications on the pharmaceutical market that have not undergone quality control, counterfeit medications, or medications illegally imported with quality deficiencies or expired shelf life; organizes, supervises, and/or carries out the safe disposal of medications with expired shelf life and quality deficiencies.
3. In the field of pharmacovigilance: registers, systematizes, and manages cases of adverse drug reactions, as well as cases related to the effectiveness of medications reported by healthcare personnel and patients; electronically transmits information on adverse reactions recorded in the Republic of Moldova to the World Health Organization (WHO) database; collects and evaluates data on medication errors, irrational use, or abuse of medications.
4. In the field of clinical studies: evaluates dossiers and provides approval for conducting clinical studies in the Republic of Moldova; monitors the conduct of clinical studies in accordance with national and international regulations; inspects the activities of clinical facilities authorized to conduct clinical studies.
5. In the field of supervision and control of pharmaceutical activities: organizes and carries out planned and unannounced inspections of pharmaceutical enterprises and institutions; exercises control over the stages of receipt, storage, maintenance, and delivery of medications and verifies compliance with technical requirements regarding the premises and facilities where they are stored; takes measures to prevent the presence of medications on the pharmaceutical market that have not undergone quality evaluation, lack origin documents, or have expired shelf life, etc.
6. In the field of coordination of medication import and pharmaceutical assistance: authorizes and monitors the import of medications and medical devices, as well as the import of medication samples, active pharmaceutical ingredients, materials, articles, primary and secondary packaging, and others used in the preparation and production of medications, in accordance with the provisions of the current legislation.
7. In the field of information and methodological organization: develops and publishes guidelines, compilations, and other materials in the field of medications and pharmaceutical activities; provides information to healthcare professionals about medications; conducts expert assessment of advertising and promotional materials for medications in accordance with the current legislation.
8. In the field of information technology: ensures the improvement and development of the Automated Information System "State Nomenclature of Medications" (SIA "NSM"); develops and implements electronic services for the e-Government program.

2023

Position Available: Senior Specialist, Quality Management Service

Requirements:

1. Development of the annual quality management plan.
2. Ensuring the implementation of strategies and objectives related to quality management with specific requirements.
3. Maintaining, implementing, and continuously improving the effectiveness of the management and quality system within the Laboratory for Drug Quality Control.
4. Maintaining and improving the quality management system within AMDM by conducting periodic internal audits.

Interested individuals are kindly requested to submit their CV to sru@amdm.gov.md or contact the phone number: 060831750 - Maria.

Please note that only shortlisted candidates will be contacted for further evaluation. The agency promotes the principle of equal opportunities in employment.

Job Opening: Cleaning Staff

Requirements:

1. Performing daily general wet cleaning in all offices, corridors, restrooms, etc.
2. Dusting. Wiping dust off furniture, flowers, radiators, sills, etc.
3. Sweeping areas that are not vacuumed.
4. Washing windows, doors, furniture, tiles, parquet, and ceramics.
5. Daily disinfection of sanitary facilities (toilets, sinks, tiles, ceramics).
6. Weekly disinfection of furniture.
7. Caring for indoor plants in halls and corridors.
8. Performing other auxiliary activities within the Agency.

Interested individuals are requested to submit their CV to sru@amdm.gov.md or contact the phone number: 060831750 - Maria.

Please note that only selected candidates will be contacted for further evaluation. The Agency promotes the principle of equal opportunities in employment.

Announcement regarding the vacancy of a public position: Chief, Quality Management Service

Regarding the organization of the competition to fill the vacant position: Head of the Quality Management Service

Regarding the organization of the competition to fill the vacant position: Senior Specialist, International Relations, Regulation, and Strategies Service

Purpose of the vacant public position, according to the job description

Developing the internationalization strategy of the Agency and ensuring its implementation, as well as effective management of the service's activities to fulfill the prerogatives of the Agency in the field of medicine, pharmaceutical activity, medical devices, and narcotics, psychotropic substances, and precursors, as well as ensuring the representation of the Agency in international organizations and structures. Ensuring compliance with the law and regulations in the field of medicine and pharmacy, as well as European Union legislation.

Main tasks of the vacant public position, according to the job description:

1. Developing and updating the internationalization strategy of the Agency;
2. Participating in the negotiation and conclusion of international agreements, memoranda of understanding, and other cooperation agreements;
3. Participating in the development and monitoring of the implementation of normative acts and guidelines in the field of medicine and pharmacy;
4. Analyzing and monitoring European and international legislation, trends, and practices in the field of medicine and pharmacy, as well as their integration into national legislation;
5. Ensuring cooperation with international organizations, foreign institutions, and structures in the field of medicine and pharmacy;
6. Providing support in ensuring the representation of the Agency in international organizations and structures;
7. Providing support in ensuring the participation of the Agency's specialists in international conferences, seminars, and other events;
8. Participating in working meetings with representatives of international organizations, foreign institutions, and structures;
9. Providing support in preparing and drafting answers to inquiries and information requests from foreign institutions and structures;
10. Ensuring the translation of documents and communication in foreign languages, in accordance with the Agency's prerogatives;
11. Providing support in organizing study visits, internships, and exchanges of experience with international institutions;
12. Ensuring the development of international cooperation relations and the strengthening of the Agency's image at the national and international level;
13. Participating in the development and implementation of the communication and promotion strategy of the Agency;
14. Ensuring the efficient organization and management of the activities of the International Relations, Regulation, and Strategies Service;
15. Performing other duties specific to the position and within the competencies established by the Agency's documents.

Type of employment

Indefinite period

Conditions for participating in the competition

1. Hold Moldovan citizenship;
2. Proficiency in the Romanian language and the official languages of interethnic communication spoken in the respective territory within the limits established by law;
3. Full legal capacity;
4. Not be older than 63 years;
5. Physically fit to perform the duties of the public position, according to the medical certificate issued by the authorized medical institution, if specific health requirements are established for the respective position;
6. Possess the required education for the respective public position;
7. Not have been dismissed from a public position according to Article 64(1)(a) and (b) or have their employment contract terminated for disciplinary reasons within the last 5 years;
8. No outstanding criminal records for intentionally committed offenses;
9. Not be deprived of the right to hold certain positions or engage in certain activities as a basic or complementary punishment, as a result of a final court judgment imposing such prohibition;
10. Not be prohibited from holding a public position or public dignity, as determined by the National Integrity Authority.

Specific requirements for participating in the competition

• Education: Higher education, bachelor's or master's degree or equivalent, in the field of medicine, pharmacy, law, international relations, or related fields;
• At least 3 years of professional experience in the field of medicine, pharmacy, law, international relations, or related fields;
• Knowledge of the legislation in the field of public service;
• Knowledge of European and international legislation in the field of medicine and pharmacy;
• Proficiency in the English language (advanced level);
• Computer skills: Microsoft Word, Excel, Power Point, Internet Explorer.

Documents to be submitted

• Application form for the public position competition (download here)
  If the application is submitted through the cariere.gov.md platform, the Application form will be automatically generated and filled in based on the data from the electronic application.
• Copy of the identity card
  Copies of the documents can be notarized or presented together with the original documents to verify their authenticity. In the case of submitting the competition file by mail or email, this provision applies on the date of the written test of the competition, under the sanction of rejecting the competition file.
• Copies of diplomas and certificates of completion of professional development and/or specialization courses
• Documents attesting professional experience
  Copy of the employment record book, certificates regarding professional activity carried out after January 1, 2019, or other supporting documents.
• Judicial record or Declaration on own responsibility
  The judicial record can be replaced by a declaration on own responsibility. In this case, the candidate is obliged to complete the competition file with the original document within a maximum of 10 calendar days from the date of being declared the winner, under the sanction of not issuing the administrative act of appointment.