Scientific Officers

Job grade: AD06

Type of position: Temporary agent

Selection procedure reference: EMA/AD/414

Job title: Scientific Officers

Deadline for applications: 15th March 2018 at 23:59 (UTC+00:00)

The European Medicines Agency is a decentralised body of the European Union with all
its offices and Headquarters currently based in London. The Agency will move to
Amsterdam, the Netherlands, by 30 March 2019 at the latest (for further information,
consult the EMA website under ‘The United Kingdom’s withdrawal from the European
Union ('Brexit')’). Its core responsibility is the protection and promotion of public health
through the evaluation and supervision of medicines.

The Agency offers a five-year renewable contract.

In case Temporary Agent posts are not available, candidates on the reserve list may be
approached to provide written consent to be considered for Contract Agent positions,
where justified in the interest of the service. These candidates will still remain on the
Temporary Agent reserve list and will still be considered for a Temporary Agent post
should a suitable post become available.

The Contract Agent position differs from the Temporary Agent post, in terms of
category, function group, grade and remuneration. For more details please see general
information on the recruitment at European Medicines Agency.

This announcement is governed by the General terms and conditions for selection
procedures for Temporary Agents.

About this role

The European Medicines Agency is seeking to build a reserve list for future extensive
recruitment of scientific officers to cover a broad spectrum of activities with a view to meeting
its current and future priorities. Candidates placed on the reserve list may, on the basis of their
specific expertise and experience, be considered for any scientific officer post that covers one or
more of the activities outlined in this vacancy text.

Job description

What tasks can I expect to perform?

The jobholder may typically be responsible, depending on his or her expertise, for activities
related to human or veterinary medicines and in roles such as, but not confined to, those
described below:

Procedural and scientific management

 Coordination of authorisation procedures concerning human or veterinary centralised

applications to ensure high quality scientific opinions/outcomes;
 Coordination of procedures to establish Maximum Residue Limits for substances
intended for veterinary use;
 Provide scientific, regulatory and/or procedural support in relation to the development,
evaluation and surveillance of medicinal products for human or veterinary use and of
Maximum Residue Limits for substances for veterinary use, submitted through the
centralised procedure;
 Provide scientific, regulatory and/or procedural support related to the management of
Community referral procedures for centrally and non-centrally authorized products for
human or veterinary use;
 Scientific support and coordination of procedures related to requests for scientific advice
(human and veterinary), orphan medicine designation or paediatric investigation plans
(human only) or Minor Use Minor Species classifications;
 Apply EU pharmaceutical legislation to the operations of the Agency as required;
 Contribute to the development of regulatory science and/or procedural guidance
documents and provide training as required.
Scientific Committee support

 Provide scientific /technical secretariat support to one of the Agency’s scientific

committees and/or working parties;
 Liaise with members of scientific committees or working parties, in particular
rapporteurs/co-ordinators to support preparation of key documents to support
committees/working parties discussions;
 Coordinate of activities related to the preparation and running of Committees and
working parties meetings including drafting of the agenda, time schedule, minutes, work
plans and evaluating existing and potential conflicts of interest of members and experts
participating in the meetings;
 Contribute to appropriate coordination between the scientific committees of the Agency.

Pharmacovigilance

 Contribute to pharmacovigilance and pharmacoepidemiology activities including safety

signal detection and evaluation, and risk management of medicines and data;
 Manage and perform analyses of safety data and information sources including individual
case safety reports (EudraVigilance data), periodic safety update reports,
pharmacoepidemiology studies, post-authorisation studies and risk management plans;
 Contribute to the development of methods, standards and guidelines in
pharmacovigilance and pharmacoepidemiology.

Communication

 Write medical information in lay language particularly the European Public Assessment
Report (EPAR) summaries or similar public information documents intended for health
care professionals, patients or the general public;
 Coordinate the Agency's relations with stakeholders within the European medicines
regulatory network.
Inspections and Quality

 Support all aspects of work related to the coordination of inspections, the compliance
status of sites of sponsors/marketing authorisation holders involved in applications
through the centralised procedure. Inspections of the Agency cover the area of Good
 Manufacturing and Distribution, Good Clinical, Good Laboratory Practice and
Pharmacovigilance;
 Provide scientific, technical and administrative support for the assessment of the quality
aspects of medicinal products;
 Regulatory, procedural or organisational management of services such as the issuance of
certificates of medicinal products or parallel distribution notifications.

Competencies

Elements that will be taken into account in determining candidates to be invited for
test/interview:

 Work experience in a national competent authority in the field of medicines regulation or

other health care authority relevant to the profile and/or
 Work experience obtained in the pharmaceutical industry which is relevant to the profile
and/or
 Work experience gained in academia which is relevant to the profile and/or
 Work experience gained in a field of consultancy relevant to the profile and/or
 Work experience gained in any other organisation/role relevant to one or more of the
roles described above.

Experience and knowledge in the following areas would be an additional advantage:

 Experience working as a Regulatory Affairs professional on EU-wide procedures or

national procedures or other work on the regulation of medicines;
 Experience in the regulatory, scientific or procedural aspects of drug development;
 Experience in the science or processes of monitoring the safety of medicines.

Experience and knowledge in the following areas may form part of the written/oral
assessment:
 1. Knowledge and understanding of scientific aspects of medicines development (such as
quality, manufacturing non-clinical and clinical development, molecular modelling,
personalised medicines, pharmacogenomics, specific aspects of safety of veterinary
medicines);
2. Knowledge and understanding of clinical trial methodology knowledge and
understanding of signal detection and pharmacoepidemiology;
3. Knowledge and understanding of statistics and/or biostatistics;
4. Clinical experience in a therapeutic field.

Essential requirements for admission

Essential requirements for admission to the selection procedure:

1. A university degree in pharmacy, medicine, science or other subject with relevance to the
regulation to human or veterinary medicines.
2. At least three years of relevant professional experience after the minimum requirement
set out under point 1 above.
3. A good command of English and a thorough knowledge of another official language of
the European Union to the extent necessary for the performance of duties (for any
promotion/reclassification in the future, knowledge of a third EU language would be
required).

For essential requirements 1 and 2 above it will be necessary to provide proof of each one
at the interview stage.

Test/interview dates

 The written eliminatory test will take place between 27 April and 4 May – only one date
will be offered. The specific date will be provided as early as possible following the
assessment of all applications.
  The interviews will take place in June and July 2018 – only one date will be offered.
The specific date will be provided as early as possible following the test results.
 Reserve list is expected by 31 July 2018

Please note that this is an indicative schedule. It is subject to change in case of unforeseen
circumstances.

______________________________________________________________________________
________________________

30 Churchill Place - Canary Wharf - London E14 5EU - United Kingdom

Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555

Email recruitment@ema.europa.eu

© European Medicines Agency, 2018. Reproduction is authorised provided the source

is acknowledged.