Scientific Officer, Compliance and Inspections, Inspections and Human Medicines Pharmacovigilance Division

The European Medicines Agency (EMA) is looking for a Scientific Officer, Compliance and Inspections, Inspections and Human Medicines Pharmacovigilance Division (AD8)

The European Medicines Agency is looking to build a reserve list for possible upcoming recruitment as a Senior Scientific Administrator to work on GXP inspections related activities with the focus to support the development of guidelines and procedures.

Furthermore, the Senior Scientific Administrator will also support the international collaboration and implementation of relevant pieces of legislation.

The Agency is a decentralised body of the European Union located in London. Its core responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines. The Agency is a multicultural organisation with staff from EU and EEA member states.

EMA works closely with the national competent authorities for human and veterinary medicines of the 28 European Member States, the three European Economic Area countries (Norway, Iceland and Liechtenstein) and the European Commission (collectively, the European Medicines Regulatory Network).

Candidates on the valid reserve list may also be considered for a different post within the same grade if the job specification and the nature of the role are similar.

Specific objectives of the jobholder:

Reporting to the Head Service of Clinical and Non-Clinical Compliance or Manufacturing and Quality Compliance, the jobholder will be responsible for the following tasks:

• Coordination of GXP (GMP, GCP, GLP and PhV) inspections as relevant
• Assistance in the development, administration and maintenance of databases (including EudraGMDP and EUdraCT)
• Provide leadership in international collaboration on GXP inspection activities
• Provide scientific, technical and administrative support for projects involving the Agency’s committees and groups of experts related to activities of the inspections department (see EMA website: Home / Human Regulatory / Inspections or Home / Veterinary Regulatory / Inspections)
• Scientific, technical and administrative support for development of guidelines and procedures
• Provide Secretariat support, as necessary, for meetings of scientific expert groups including inspectors’ working groups
• Providing responses to external queries on inspection and related matters
• Manage a portfolio of products including coordination of suspected quality defects
• Secretariat support, as necessary, for meetings of scientific expert groups including inspectors’ working group
• Support the development of training programme, in conjunction with the GXP Inspectors Working Groups, for use to support these groups’ activities and contributions to international training programmes and capacity building
• Represent the Agency in external fora
• Support to the implementation of relevant pieces of legislation, e.g. Clinical Trial Regulation

Deadline for submission of application forms is 14 August 2015 at midnight

Read more and apply here.