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.
- 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.
- 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
- 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
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
- 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
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.