Support implementation XEVMPD - IDMP 2042

20-8-2019 bruxelles
company profile

Regulatory Affairs Operations Europe (RAO-EU)

job description

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...)

your contribution

- 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 : 

  • Group insurance
  • Hospitalisation insurance
  • Meal vouchers of 7 euros gross per working day
  • Reimbursement km or company car 
  • Monthly allowance (50 euros net per month)
  • A 13th month
  • Training
  • Etc

A rate as freelance is also possible

summary
function
project manager (m/f)
employment type
full time, freelance
contract type
immediate permanent employments
reference
CXRSP-84496
your Randstad contact
Aurélie Osée
aurelie.osee@cx.ausy.be 02 474 60 16
02 474 60 16