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Regulatory Affairs Consultant (xEVMPD/IDMP/RIMS) Reference number: 1047
Last update: 13-08-2019, 16:57
Region: Brussels
Sector: PHARMA
Education: Bachelor degree in scientific domain
Start: 02 Sep 2019    End: 31 Dec 2019
3 months
Work experience: 3 years in pharmaceutical or regulatory affairs domain
Job description
In the context of the EU PV legislation 1235/2010 (XEVMPD/Article 57), our client is transitioning the maintenance and submission of structured information on medicinal products to the EMA using the internal RIM system (based on Liquent InSight).

The Regulatory Affairs Operations department is looking for an Analyst with technical capabilities to join the XEVMPD-IDMP Team in Brussels offices.
What you’ll do
  • Finalize the transition of XEVMPD processes and data from manual encoding (based on EV Web) to the internal RIM System based on Liquent InSight
  • Define and implement improvements of the XEVMPD processes once live
  • Participate to the data quality and compliance monitoring of the XEVMPD submission process
  • Initiate the company transition from XEVMPD to IDMP in the EU, with a primary focus on the data extraction from submission documents into data repositories (process, quality review, possibly automation…)
Profile
  • Bachelor degree in scientific domain
  • Language: fluent English, and knowledge of another EU language is highly desirable
  • Experience: 3 years in pharmaceutical or regulatory affairs domain
Required Skills
  • Experience in pharmaceutical/regulatory domains
  • Experience with a pharmaceutical company RIM System
  • Technical capabilities in managing large volumes of data
  • Quality and analytics during execution
  • Autonomy
  • Knowledge of XEVMPD submissions to the EMA is a plus
  • Knowledge of IDMP in the EU is a plus
  • Experience with data structure of medicinal products in the world
  • Experience with Liquent InSight
  • Experience with SharePoint and Excel
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