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Regulatory Affairs Operations Europe (RAO-EU)
Are you ready to help a big pharmaceutical company through the implementation of XEVMPD - IDMP?
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 medical products to the EMA.
The Regulatory Affairs Operations department is looking for an Analyst with technical capabilities to undertake the following activities:
- finalize the transition of XEVMPD processes and data from manual encoding (based on EV Web)
- 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...)
- Bachelor degree in scientific domain
- Languages : English and knowledge of another EU language is highly desirable
- Experience : 3 years in pharmaceutical or regulatory affairs domain
- Experience with a RIM system
- Technical capabilities on management large volumes of data
- Experience with Liquent InSight
what do we offer?
We offer an attractive salary with extra-legal advantages :