Regulatory Operations Specialist

  • Lieu : Brussels
  • Type de contrat : Contrat à durée indeterminée
  • Débute le : 26 novembre 2019

Descriptif de fonction

As a Regulatory Operations Specialist you will be responsible for managing the submissions of medicinal product data to the European Medicines Agency (EMA), following the pharmacovigilance (PV) legislation EU 1235/2010, Article 57.

This includes:

  • The Quality Control of submission-ready product information notified by the Data Owners (Regulatory Affairs in the Regional Center and the European Economic Area Countries (EEA Countries),
  • The submission of product information data to the EMA,
  • The follow-up of EMA feedback, the transversal monitoring of Data Quality within source systems, the monitoring of compliance of the company with respect to the Article 57/XEVMPD requirements,
  • The support to downstream data consumers and other tasks to support the use of the standard.

Primary Activities:

  • Collect product information notified by Regulatory Affairs Data Owners and perform Quality Checks (completeness, adherence to requirements, adherence to process) before submission
  • Prepare the product information data submission, and submit to the European Medicines Agency (EMA)
  • Manage the receipt of EMA feedback on submissions (acknowledgements) and complete the submission process as appropriate, including archiving
  • Track the submissions to the EMA and feedback received from the EMA to compliance monitoring
  • Support Quality-driven activities arising from external and internal requests
  • Support the data consumption of product information data to downstream users within Regulatory Affairs, Pharmacovigilance, Manufacturing, etc.
  • Participate in ISO IDMP-related initiatives in the company

Compétences

  • Attention to details
  • Excellent written and oral communication skills in English
  • Good knowledge of Dutch or French is required
  • Comfortable working with IT systems and large/complex data sets

Expériences

Minimum of bachelor's degree or above is required

Relevant business experience is desirable in the following domains:

  • Medicinal product information (structure of information on medicinal products and substances)
  • Pharmacovigilance regulation (regulation 1235/2010 and related Article 57 materials)
  • Knowledge of EU/EEA Regulatory Affairs environment
  • Practical experience (min. 2 years) with systems supporting Article 57, including EV Web
  • Practical experience (min. 1 year) with regulatory information systems (RIM), (e.g. Liquent InSight for Registrations and the XEVMPD Module or similar application)
  • Experience in multicultural organizations is desirable

Project experience:

  • Attention to details, data compliance, data quality and data integrity – ALCOA principles (Attributable, Legible, Contemporaneous, Original, and Accurate)
  • Document and records management, content management, datamanagement
  • Online transactional processing systems and tracking systems
  • In relation to the relevance of the project, 2 years in the business domain are required

Avantages

Evolia is continuously growing and tends to hire highly motivated professionals in order to cover more geographical and industrial fields.
You will receive a permanent contract with competitive salary supplemented with attractive fringe benefits such as company car with fuel card, communication allowance, representation allowance, mobile, internet@home, hospitalization and group insurances.
20 holidays and 12 compensatory days an access to continuous training.

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