The Regulatory Affairs Operations department is looking for an Analyst with technical capabilities to join the XEVMPD-IDMP Team in Brussels offices.
He/she will undertake the following activities:
§ 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…)
- Bachelor or Master's degree in scientific domain.
- Fluent in English. Any other EU language is a plus.
- 3 years in pharmaceutical or regulatory affairs domain.
- IT minded.
What we offer
Who we are
Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park - Drève Richelle 161 - Waterloo
- Nijverheidslaan 3, - Strombeek Bever