Medicines Authority
Posts of Medical Assessor
(Jobsplus Permit No: 998/2024)
1. The Medicines Authority invites applications for the Post of Medical Assessor within the Authority.
2. Terms and Conditions
2.1. The selected candidate will be employed as a Medical Assessor within the Medicines Authority.
2.2. The Post of Medical Assessor is subject to a probationary period of twelve (12) months.
3. Salary pegged to the Post
The remuneration package for the Medical Assessor shall be aligned with Consultant Contract B pay package of the Sectorial Agreement for the Medical Association of Malta.
4. Duties
The mission of the Malta Medicines Authority is to safeguard public health through the regulation of medical products and pharmaceutical activities for human use.
Overall purpose
The Medical Assessor works as part of a human medicines multi-disciplinary assessment team that is responsible for deciding on whether a medicine is safe enough to progress into clinical trials, whether there is a positive balance of benefits over risks prior to marketing a medicine and whether additional safety measures need to be taken after marketing. The Medical Assessor provides scientific advice to drug developers on their clinical development programmes, including how a clinical trial should be designed and the regulatory routes to market.
Functions
(a) Participate in and lead:
- Applications for medicinal product pre and post authorisation including the documentation and other evidence submitted in support of the safety, quality and efficacy of medicinal products;
- Preparation of summaries and reports arising from evaluations; and
- Meetings of the Advisory Committees in Malta and abroad, as required.
(b) Review:
- Documentary evidence purporting to support any proposed amendments or variations to safety and efficacy information of authorised products;
- Documentation submitted in support of applications for approval to renew authorisations for marketed products;
- Technical assessment of safety, efficacy and quality data submitted in support of applications to conduct clinical trials in respect of human medicinal products (containing new chemical entities or established active ingredients);
- Documentation submitted in support of applications for scientific advice;
- Submitted reports as required and maintain appropriate records of meeting and activities; and
- Post-marketing surveillance duties concerning pharmacovigilance including ADRs/Signal detection PSURs/PIPs and their modifications/PASS and PAES studies.
(c) Ensure:
- Continuous engagement in updating and ensuring knowledge of state-of-the-art technologies and updated standards and guidelines through ongoing professional education and review of published literature, including training requirements and training sources;
- Communication with applicants, health care professionals and any other relevant persons in relation to the above evaluations including liaison with fellow officers, both medical, preclinical and pharmaceutical;
- Maintenance of post-marketing surveillance by checking literature and reports in relation to clinical experience with products, assisting with side effect and quality defect reports as necessary;
- Appropriate medical representation at relevant European committees and working groups;
- Activities meet requirements in terms of accuracy, completeness and timeliness;
- Submission of reports as required and maintain appropriate up-to-date records of meetings and activities;
- Timely planning, delivery and oversight of the procedures in line with the strategy of the Malta Medicines Authority and the resources available;
- Compliance with the quality management system of the Malta Medicines Authority and regulatory requirements, including development and update of quality documents and standards; and
- Documentation and implementation of all policies and Standard Operating Procedures.
(d) Provide:
- Analysis in the context of public health, of risk-benefit profiles in respect of applications for marketing authorisation in accordance with pharmacovigilance procedures;
- Relevant and consistent information and appropriate medical advice to the Chief Executive Officer/Director/s and staff under the direction of the assigned Director, committees, government department, professional bodies and other bodies, as appropriate;
- Advice to committees established to provide guidance or overview the assessment process or any other procedure of the Authority; and
- Technical assistance and scientific output/assessment, as required.
(e) Continuously improve the performance of the organisation by:
- Formulating medical assessment policy and practice;
- Working with colleagues, particularly with the Directors to ensure the provision of adequate and continuous professional development for the Authority;
- Promoting and maintaining good professional and ethical working relationship with colleagues and stakeholders;
- Promoting communication and liaison between different sections of the organisation;
- Representing the Authority at meetings, including meetings of the Committees/ Working Groups, seminars, conferences and other fora, both locally as well as abroad;
- Encouraging and ensuring the effectiveness and efficiency of the quality of service; and Promoting the vision, mission, values, strategy and objectives of the Authority.
(f) Any other duties and responsibilities as assigned by the Chief Executive Officer/Director/s and/or appointed substitute.
5. Eligibility requirements
5.1 By closing time and date of this call for applications, applicants must be:
i. Proficient in the English language
ii. Registered as a medical practitioner with the Medical Association of Malta
iii. In possession of:
a. Five (5) years of service in clinical practice (following full registration).
b. Experience in research in the academic, clinical, or industrial fields of medicine.
c. Experience in the evaluation of medicinal products.
6. Submission of supporting documentation
6.1 Qualifications and experience claimed must be supported by certificates and/or testimonials, copies of which should be attached to the application. Scanned copies sent electronically are acceptable.
6.2 Original certificates and/or testimonials are to be invariably produced for verification at the interview.
7. Selection procedure
Eligible applicants will be assessed by a Selection Board to determine their suitability for the Post.
8. Submission of applications
Applications, together with a curriculum vitae showing qualifications and experience and a signed Data Protection consent statement (Appendix 1), are to be submitted to hr.medicinesauthority@gov.mt by not later than noon on 9th November 2024.