Medicines Authority

Posts of Senior Pharmacist

(Jobsplus Permit No: 662/2023)

1. The Medicines Authority invites applications for the Post of Senior Pharmacist within the Authority.

2. Terms and Conditions

2.1. The selected candidate will be employed as a Senior Pharmacist Grade BI, according to the Medicines Authority Collective Agreement.

2.2. The Post of Senior Pharmacist is subject to a probationary period of twelve (12) months.

3. Salary pegged to the Post

3.1 The salary attached to the post of Senior Pharmacist in 2022 is that of €25,695 per annum, rising by annual increments up to a maximum of €29,412.

3.2 Other benefits include a non-pensionable market corrector allowance of €7500 per annum, a Cash Allowance of €1270 per annum, reimbursement of a maximum of €1164.68 per annum for Continued Pharmacy Education, payable at the discretion of the Chief Executive Officer of the Medicines Authority. For the latter allowance, payments are subject to submission of receipts, etc. as applicable. A Qualification Allowance (if applicable) as established by the Central Administration in line with the Medicines Authority Collective Agreement.

4. Duties

Overall purpose

The Senior Pharmacist is responsible to carry out regulatory and technical pharmaceutical duties related to the regulation of medicines, medical devices and pharmaceutical activities. The Senior Pharmacist shall be required to give professional service and work as part of a multi-disciplinary team.

Functions

(a) Participate in and lead:

-Technical meetings;

-Procedures related to the registration and life-cycle management of medicines;

-Inspections of pharmaceutical activities in Malta and abroad;

-The post-marketing surveillance programme;

-Pharmacovigilance procedures;

-Enforcement of regulations governing medicinal products and/or medical devices;

-The regulation of cannabis for medicinal and research purposes;

-Other functions, including Assessment of Advertising and Promotional Material, as well as other boards or committees as required;

-Research and development projects, as required; and

-Other ongoing projects as required.

(b) Review:

-Technical data submitted in support of applications of medicinal products (including different procedures), medical devices and medicinal cannabis-based products, in accordance with established procedures;

-Monitor, transpose and implement legislation, guidelines, etc; and

-Published literature.

(d) Execute duties in a professional manner:

-By keeping up to date with the knowledge required for the work assigned;

-By operating any software package or procedure provided by management;

-Through continuous self-monitoring to improve scientific capabilities; and

-To contribute to the efficiency and effectiveness of the Malta Medicines Authority.

(e) Ensure:

-Liaison with, and provision of advice to, applicants and professional colleagues in order to facilitate the review process;

-Liaison with, and provision of advice to, Committees established to provide guidance on or overview of the assessment process;

-Prioritisation of required duties without supervision;

-Compliance with the set standards, protocols, regulatory requirements and the quality management system of the Authority;

-Documentation and implementation of all Policies and Standard Operating Procedures; -The timely processing of tasks and issues for the respective Directorate/ Unit; and -The efficient use of the Authority’s resources in a cost-effective manner.

(f) Provide:

-Relevant and consistent information and advice to the Director/s and staff under the direction of the assigned Director;

-Expert regulatory and procedural advice and support;

-Advice to the Chief Executive Officer / Directors as required, seeking to propose strategic solutions to the challenges in this area;

-Strategic direction in the relevant assigned field in line with the strategy and vision of the Authority; and

-Pharmaceutical technical assistance, as required.

(g) Continuously improve the performance of the organisation by:

-Promoting and maintaining good professional and ethical working relationship with colleagues and stakeholders;

-Promoting communication and liaison between different sections of the organisation;

-Performing duties pertaining to other staff and deputise according to the exigencies of the services;

-Representing the Malta Medicines Authority at meetings, seminars, conferences and other fora, both locally as well as abroad;

-Observing, promoting and ensuring the effectiveness and efficiency of the quality management system;

-Preparing policies, guidelines and standard operating procedures;

-Managing assigned office in line with the direction of the relevant Director/Head and Top Management;

-Training, motivating, supervising and monitoring other colleagues, as may be required; and

-Promoting the vision, mission, values, strategy and objectives of the Authority.

(h) Any other duties and responsibilities as assigned by the CEO and Director/s.

5. Eligibility requirements

5.1 By the closing time and date of this call for applications, applicants must be:

(i) Proficient in the English Language.

(ii) In Possession of:

(a) A recognised Master qualification at MQF Level 7 (subject to a minimum of 60 ECTS/ECVET credits, or equivalent, with regard to programmes commencing as from October 2008) in pharmacy or life sciences or related area, plus one (1) year relevant work experience, preferably in regulatory affairs. Experience in the management of European procedures will be considered an asset.

Or

(b) A recognised Bachelor qualification at MQF Level 6 (subject to a minimum of 180 ECTS/ECVET credits, or equivalent, with regard to programmes commencing as from October 2003) in pharmacy or life sciences or related area or a comparable professional qualification plus three (3) years relevant work experience, preferably in regulatory affairs. Experience in the management of European procedures will be considered an asset.

(iii) In possession of a warrant to practice as Pharmacist in Malta.

Candidates who have not yet formally obtained the requisite specified in paragraph 1(ii) above will still be considered, provided that they submit evidence that they would qualify for such requisite by end of year 2023 and, in any case, before being appointed to the post.

5.2 Prospective applicants should note the requirement to produce MFHEA recognition statements in respect of their qualifications from MFHEA, or other designated authorities, as applicable, as per provisions applicable to this call for applications. Such statement should be attached to the application and the original presented at the interview.

5.3 Applicants who are not in possession of the requisite at 5.2 above may still apply, provided that they submit a copy of the statement to the receiving department/directorate as soon as it is available, and, in any case, by not later than six (6) months from the closing date of the call for applications. Applicants may be assessed provisionally whilst still awaiting MQRIC equivalence of their qualification/s. Should the equivalence report be in the negative

or not presented within six (6) months from the closing date of the call for applications, such applicants will be disqualified from the selection process.

5.4 No recognition statement by MQRIC is required in respect of qualifications issued by Maltese self accrediting institutions or any Maltese qualification that has been accredited by the MFHEA.

5.5 The appointment of Third Country Nationals will be without prejudice to the applicant satisfying all eligibility requirements specified in paras 5.1 to 5.4 above and being granted a work permit in line with the Single Permit Regulations (Subsidiary Legislation 217.17, of the Laws of Malta) as well as being able to fulfil all other conditions of entry into the Schengen territory. Each process is carried out independently and subject to due diligence processing by the competent Maltese Authorities. Applicants who fail to satisfy these requirements within (6) six months from the closing date of the call for applications will be disqualified from the selection process.

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 23rd September 2023.