Post of Safety Assessor

 

Malta Medicines Authority

Post of Assessor (Safety) - (Jobsplus Permit No: 202/2021)

 

1. The Malta Medicines Authority invites applications for post of Assessor (Safety) within the Authority.

 

2. Terms and Conditions

 

2.1. The selected candidate will be employed as a Professional Officer Grade A, on an indefinite contract with the Authority, according to its Collective Agreement.

 

2.2. The post of Assessor (Safety) 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 Assessor (Safety) for 2021 is that of €29,884 per annum.

 

3.2 Other benefits include a non-pensionable Pharmacist Class Allowance of €8500 for candidates who are registered pharmacists and a Cash Allowance of €1466 per annum.

 

A 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. 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 Assessor (Safety) will:

 

-Evaluate the risks of medicinal products for human use;

-Work as part of multi-disciplinary team that will be responsible for assessing and evaluating quality, safety and efficacy data of medicinal products; and

-Perform post-marketing surveillance duties concerning pharmacovigilance, signal detection and pharmacoepidemiology, as required.

 

4.1 Key responsibilities

 

Functions

 

(a)   Assists line management in:

 

-Technical and scientific duties;

-Compilation of publications and reports; and

-Day to day management.

 

(b)   Evaluate:

 

-Applications for product authorisations including the documentation and other evidence submitted in support of the safety, quality and efficacy of the products;

-Safety data submitted in support of applications to conduct clinical trials in respect of human medicinal products (containing new chemical entities or established active ingredients); and

-Documentary evidence purporting to support any proposed amendments or variations to safety information of authorised products.

 

(c)   Prepare:

-Summaries and reports arising from evaluations;

-Analysis of risk-benefit profiles in respect of applications for marketing authorisation in accordance with pharmacovigilance procedures, in the context of public health; and

-And formulate safety assessment policy and practice.

 

(d)   Ensure:

 

-Checking of literature and reports in relation to clinical experience with medicinal products, and assisting with side effect and quality defect reports, as necessary, in order to maintain post-marketing surveillance;

-Provision of technical advice;

-Representation at relevant European committees and working groups;

-Communication with applicants, practitioners and any other relevant persons in relation to the above evaluations including liaison with fellow officers, medical, preclinical and pharmaceutical;

-Submission of reports as required and maintain appropriate records of meeting and activities;

-Timely planning, delivery and oversight of the procedures in line with the Authority’s strategy and the resources available;

-Facilitation of engagement and dialogue with Marketing Authorisation Holders, prospective companies and staff of the Authority in line with Top Management direction;

-Staff receives the necessary training to achieve their potential, by using delegation and empowerment to provide opportunities to develop staff and to plan for succession;

-Compliance with the set standards and the quality management system of the Authority; and

-Documentation and implementation of all policies.

 

 

 

 

(e)   Spearhead, coordinate and implement:

 

-Activities of the MMA;

-Assigned procedures;

-Ongoing and new projects within the Pharmacovigilance Directorate; and

-Any other delegated projects and assignments.

 

(f)    Provide:

 

-Relevant and consistent information and advice to Director/s and staff under the direction of the assigned Director, committees, government department, professional bodies and other bodies, as appropriate;

-Support to staff in order to maximise their potential, in turn delivering the work in an efficient and effective manner and in line with the policies and guidelines of the Authority;

-Advice to the Chairperson/ Directors as required, seeking to propose strategic solutions to the challenges in this area; and

-Technical assistance and scientific output/assessment.

 

(g)   Monitor and report performance against the key performance indicators for the area assigned.

 

(h)   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;

-Representing the Medicines 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;

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

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

 

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

 

 

 

 

5. Eligibility requirements

 

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

(i) (a) citizens of Malta; or

(b) citizens of other Member States of the European Union who are entitled to equal treatment to Maltese citizens in matters of employment by virtue of EU legislation and treaty provisions dealing with the free movement of workers; or

(c) citizens of any other country who are entitled to equal treatment to Maltese citizens in matters related to employment by virtue of the application to that country of EU legislation and treaty provisions dealing with the free movement of workers; or

(d) any other persons who are entitled to equal treatment to Maltese citizens in matters related to employment in terms of the law or the above-mentioned EU legislation and treaty provisions, on account of their family relationship with persons mentioned in paragraph (a), (b) or (c); or

(e) third country nationals who have been granted long-term resident status in Malta under regulation 4 of the “Status of Long-Term Residents (Third Country Nationals) Regulations, 2006” or who have been granted a residence permit under regulation 18(3) thereof, together with family members of such third country nationals who have been granted a residence permit under the “Family Reunification Regulations, 2007”.

The advice of the Citizenship and Expatriates Department should be sought as necessary in the interpretation of the above provisions.

 

The appointment of candidates referred to at (b), (c), (d) and (e) above would necessitate the issue of an employment licence in so far as this is required by the Immigration Act and subsidiary legislation. The Jobsplus should be consulted as necessary on this issue.

(ii) Be in possession of:

(a) A recognised Doctorate qualification at MQF Level 8 in Pharmacy or a comparable professional qualification, plus minimum of two (2) years relevant work experience of which at least one (1) year in the management of  EU procedures for authorisation of medical products and/ or regulatory affairs and/or review of safety (pharmacovigilance/pharmacoepidemiology/clinical trials/pre-clinical data) and/or quality of medicines.

 

Or

 

(b) A recognised Master qualification at MQF Level 7 in Pharmacy or a comparable professional qualification, plus minimum of three (3) years relevant work experience of which at least two (2) years in the management of  EU procedures for authorisation of medical products and/ or regulatory affairs and/or review of safety (pharmacovigilance/pharmacoepidemiology/clinical trials/pre-clinical data) and/or quality of medicines.

 

Or

 

(c) A recognised Bachelor qualification at MQF Level 6 in Pharmacy or a comparable professional qualification, plus a minimum of five (5) years relevant work experience of which at least three (3) years in the management of  EU procedures for authorisation of medical products and/ or regulatory affairs and/or in the review of safety (pharmacovigilance/pharmacoepidemiology/clinical trials/pre-clinical data) and/or quality of medicines.

 

(iii) Proficiency in the English Language;

 

 (iv) Be a Registered Pharmacist with the local Pharmacy Council.

 

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 noon on 8 May 2021.