Job opportunities

Call for expression of interest for National Experts on Secondment (EMEA, London)

Published: 07/05/09

EMEA wishes to set up a permanent list of scientific candidates interested in a short-term work opportunity as National Expert on Secondment. Applications to become a National Expert on Secondment will be kept for three years. The spirit of the rules on National Experts on Secondment is to enhance and develop the relationship between European public administrations. Candidates MUST have current employment in the Public Sector (such as University, Research Institute, Public hospital or Regulatory body) of one of the member states of the European Union and a good level of English, the language in which the EMEA mainly works.

General conditions: For the duration of the secondment contract, the EMEA may reimburse all or part of the gross remuneration to the current employer, pays a monthly travel allowance based on the distance to the place of deemed residence and provides a daily subsistence allowance of up to £123 per day, (please consult the 'Rules applicable to on National Experts on secondment to the EMEA' for more details). The contract is not renewable and does not lead to subsequent employment at the EMEA. The contract duration is for full time employment and is generally 12 to 18 months (to be agreed with the current employer).

The EMEA is a multicultural work environment, and the working language is English.

The EMEA is located in Canary Wharf, London, UK.

Please send CV, contact details and letter of motivation in English to

Ms Frances Nuttall
Head of Personnel
EMEA
7 Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom

Positions immediately available

Expert on Secondment for Pharmacovigilance and Risk Management Sector

A number of positions are immediately available in the Pharmacovigilance & Risk Management Sector of the Unit for the Post-Authorisation of Medicines for Human Use - European Medicines Agency. The contract start is as early as possible. All positions are on a full time basis for 12 months initially, at the EMEA (London, UK).
The Sector’s central responsibility is the co-ordination of the EU pharmacovigilance and risk management activities and the support of the scientific committee as regards the continuous monitoring and evaluation of the safety of medicines. Important resources to assist these activities are EudraVigilance, the European database of adverse reactions related to medicines authorised in the Community and the European Pharmacovigilance Information Tracking Tool (EPITT). In addition, the Sector manages the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) project intended to further strengthen the post-authorisation monitoring of medicinal products in Europe by facilitating the conduct of multi-centre independent post-authorisation safety studies. The Sector is also taking a lead in defining EU business requirements in the context of the international standardisation work related to the electronic reporting of Individual Case Safety Reports (ICSRs) and the Identification of Medicinal Products (IDMP).

Requested qualifications:
Successful candidates are likely to have a university degree in life sciences, medicine, pharmacology or pharmacy. A very good knowledge of English with excellent written and oral communication skills is required. Experience and knowledge in at least one of the following areas would be an advantage:

Operational experience in pharmacovigilance and/or pharmacoepidemiology including aspects such as data collection and management, signal detection and evaluation, benefit risk assessment, decision-making, risk management and risk communication
Experience in the design, conduct and evaluation of pharmacovigilance and epidemiological studies
Experience in working with committees and networks in the area of pharmacovigilance or pharmacoepidemiology
Knowledge of EudraVigilance and MedDRA including experience in data analysis of adverse reaction and medicinal product data

Job description

To work at the EMEA providing operational support in one or more of the following areas:

Signal detection and evaluation for centrally authorised medicinal products
Management and administration of EPITT
The peer review of EU Risk Management Plans (EU-RMPs) and the examination of the Interface between the EU-RMPs and EudraVigilance
Data collection and management related to EudraVigilance and organisation of data quality review meetings with pharmaceutical industry
Support to the ENCePP project
The drafting of guidelines, standard operating procedures and work instructions
The international standardisation work in the frame of ICH and ISO
The conduct of research into the methodologies of pharmacovigilance

Expert on Secondment for Safety of Veterinary Medicines Sector

A position is immediately available in the Safety of Veterinary Medicines Sector – European Medicines Agency.

Requested qualifications:

Successful candidates are likely to have scientific training in one of the life sciences, preferably with relevance to the activities described below. A good command of English is required. Experience relevant to the particular area described below and previous administrative experience would be an advantage.

Job description:

The main area of activity will be to support the sector with referrals and arbitrations to the Committee for Medicinal Products for Veterinary Use concerning safety issues related to authorisation and use of veterinary medicinal products. Involvement may also be possible in specific projects run by the sector related to limiting the potential risk to man from the use of antimicrobials in veterinary medicine, environmental risk assessment of veterinary medicinal products and outcomes assessment related to the setting of Maximum Residue Limits.

Expert on Secondment for Quality of Medicines Sector

Two positions are immediately available in the Quality of Medicines Sector of the Unit for the Pre-Authorisation of Medicines for Human Use – European Medicines Agency.

Requested qualifications:

Successful candidates are likely to have scientific training in pharmacy or other life sciences with relevance to the activities described above. Specific training and/or experience in fields such as biotechnology and emerging technologies (e.g. cells, nanotechnology) and chemical entities (e.g. bioequivalence) would be appreciated. A good command of English is required.

Job descriptions:

Working with the Biologics Working Party on quality of biotech and biological products.
Managing procedures for centrally authorised biotech and biological medicinal products.
New technologies (e.g. gene therapy, cell therapy).
Arranging Expert Workshops and Training Sessions.
Working with the Quality Working Party on quality of chemical products.
Managing procedures for centrally authorised new chemical and generic medicinal products.
New technologies (e.g. chemical aspects of nanotechnology).
Arranging Expert Workshops and Training Sessions

Expert on Secondment for Paediatrics

A position is available in the Scientific Advice and Orphan Drugs Sector of the Unit for the Pre-Authorisation of Medicines for Human Use - European Medicines Agency. The contract start is as early as possible. This is a full time position for 12 to 18 months, at the EMEA (London, UK).

Requested qualifications:

Medical Doctor with a qualification or significant experience in paediatric medicine or paediatric pharmacology, and/or clinical trials in children.

Job description:

To work at the EMEA on all scientific questions related to drug development in children, and other aspects of the implementation of the European Paediatric Regulation.

The Scientific Advice and Orphan Drugs Sector is a high profile sector within the EMEA, which is responsible for advising companies on the scientific aspects of pharmaceutical and biotech quality, efficacy and safety of medicinal products for human use, and supports the Scientific Advice Working Party of the Committee for Medicinal Products for Human Use, which includes experts from academia and assessors from national medicines agencies. The Sector also supports the Committee for Orphan Medicinal Products as it is in charge of orphan drug designation, which provides incentives for drugs intended for rare diseases.

The Expert on Secondment is expected to use his/her expertise in assessing paediatric development plans for medicines intended for use in children, as proposed by pharmaceutical companies or sponsors of clinical trial s, and contributing to paediatric scientific advice .

More information on the European initiative on the European Paediatric Regulation can be found here: http://www.emea.europa.eu/htms/human/peg/pegfaq.htm and the most recent text of the Paediatric Regulation (Council Common Position 2006, preceding the second EP reading): http://www.europarl.europa.eu/oeil/file.jsp?id=5210532

Expert on Secondment for Scientific Advice

A position is immediately available in the Scientific Advice and Orphan Drugs Sector of the Unit for the Pre-Authorisation of Medicines for Human Use - European Medicines Agency. The contract start is as early as possible.

Requested qualifications:

Medical Doctor with a qualification or significant experience in clinical trials and/or methodology of clinical trials, or in a medical specialty (e.g. cardiology, pneumology, internal medicine).

Job description:

To work at the EMEA on Scientific Advice requests and procedures, and all scientific questions related to drug development.

The Scientific Advice Sector is a high profile sector within the EMEA, which is responsible for advising companies on the scientific aspects of pharmaceutical and biotech quality, on preclinical development and all issues of clinical efficacy and safety of medicinal products for human use. The Sector supports the Scientific Advice Working Party of the Committee for Medicinal Products for Human Use, which includes experts from academia and assessors from national medicines agencies.

The Expert on Secondment is expected to use his/her expertise in drafting advice to pharmaceutical companies or sponsors of clinical trials for the development of medicines in various therapeutic areas.

Expert on Secondment for Safety & Efficacy

Two position are available in the Safety & Efficacy Sector of the Unit for the Pre-Authorisation of Medicines for Human Use - European Medicines Agency (EMEA).

Requested qualifications:

Medical Doctors with a qualification or significant experience in oncology, central nervous system, endocrinology/diabetes or cardiovascular system are preferable, although good background and training in internal medicine is valuable.

Job description:

To work at the EMEA on Safety & Efficacy of Medicines requests and procedures, and all scientific questions related to the concerned therapeutic area.

The Safety & Efficacy is a high profile sector within the EMEA, which is responsible for the safety and efficacy aspects of the evaluation process for centralised marketing authorisation applications from pre-submission stage right through assessment, adoption of the final scientific opinion by the Committee for Medicinal Products for Human Use (CHMP) and publication of the European Public Assessment Report (EPAR), as well as for arbitrations and referrals, emerging therapies and the secretariats of CHMP Working Parties and Scientific Advisory Groups in the fields of Diabetes/Endocrinology, Anti-infectives, Diagnostics, HIV/Viral Diseases, Central nervous System and Oncology.

Expert on Secondment for Inspections Sector

Requested qualifications:

Appropriate scientific qualification and significant experience in the GxP area

Job description:

To work at the EMEA on GxP related requests and procedures

The Sector is responsible for co-ordinating inspections requested in connection with the assessment of marketing authorisation applications and/or the assessment of matters referred to by the Scientific Committees in accordance with Community legislation. These inspections may cover GCP, GLP, GMP, Pharmacovigilance (PhV) or they may be performed in the context of Vaccine Antigen Master File (VAMF) or Plasma Master File (PMF) certification. The Sector organises and chairs regular meetings of GCP and GMP inspectors where harmonisation of inspection related procedures and guidance documents are developed and it provides secretarial support to the joint CHMP/CVMP Quality Working Party. Communication and action by Member States in response to Quality Defects relating to centrally authorised medicines are also coordinated by the Inspections sector. More information on the sectors activities is available from EMEA's website under Inspections.