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EudraVigilance Application Assistant for multinational client in Amste

Posted on Mar 11, 2020 by infeurope S.A.

Amsterdam, Noord-Holland, Netherlands
IT
Immediate Start
Annual Salary
Contract/Project

We are looking for a EudraVigilance Application Assistant for multinational client in Amsterdam

Expected tasks and deliverables by the Consultant

  • Registration of various external stakeholders (NCAs, MAHs, Sponsors and Contract Research Organisations), as well as internal Agency
  • Ensuring the correct EV registration process E2E
  • Assessing individual cases to ensure that they have been created in accordance with relevant Agency standards requirements,
  • Ensuring that that issues on EV registration queries have been solved
  • Providing support to external stakeholders in below areas: reporting obligations of the various stakeholders;
  • Liaison with administrative and operation staff from National Competent Authorities and the pharmaceutical industry as well as with different teams in the management and coordination of the different registration processes
  • Quality management and maintenance of registration data - data management
  • Screening and verification of various confidential documents required as part of the established registration processes
  • Evaluating the overall work performed using the statistical data analysis tools,
  • Ensuring the soundness of follow-up procedures, and that these are being correctly followed,
  • Using sound judgement to escalate and request advice when the quality or quantity of work performed is below agreed thresholds,
  • Acting as a principal contact for both internal and external queries relating to the EV Registration process,
  • Supporting continuous improvement through identification and implementation of process improvements/simplifications in conjunction with the business requirements.

Educational and experience

  • Secondary Education attested by a diploma and at least 1 years of professional experience as EudraVigilance Application Assistant
  • Experienced on registration processes or IAM
  • Capability of integration in an international/multicultural team and good communication skills in English - level C1/C2 (effective operational proficiency or advanced)

General skills:

  • Attention to details
  • Reporting skills
  • Team player with a willingness to offer and provide help to non-technical users;
  • The ability to work in unusual situations, flexibility and a willingness to undertake tasks not directly related to the job description;
  • Good problem-solving skills; ability to visualize a problem or situation
  • Ability to handle a constantly changing flow of traffic
  • Ability to provide support over the phone; good phone skills,

Advantage:

  • ITIL V3 foundation certification
  • Pharma companies' knowledge
  • Knowledge of MS Office, Windows 7 and 10;
  • Previous IT Service Desk experience;
  • IT background

infeurope is a Luxembourg-based IT service provider, designing, developing and managing multilingual information and documentary systems in many application areas and business sectors. For more than 37 years we have delivered IT systems and solutions.

Reference: 860843299

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