Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
What we offer:
o Reply to case management e-mails from the platforms,
o Monitoring of case processing times, identification of reasons for delays in reporting/transmission of cases…..,
o Participation in weekly quality control of case processing (data entry, coding, narrative writing):
– Editing listings, checking data against source documents and overall consistency of data,
– Provision of listings with corrections or requests for clarification in the platforms’ SharePoint,
– Verification of platform response and corrections or requests for clarification,
– Quality control signature.
o Participation in quality control of clinical study case narratives provided by the platforms for inclusion in the clinical study report,
o Participation in supervising the reconciliation of pharmacovigilance cases with partners (SDEA) and cases with the clinical database outsourced to platforms.
Minimum Requirements :
* Physician, Pharmacist, with a specialty in Pharmacology, Pharmacovigilance, Toxicology.
* One to three years’ experience in a similar position (industry or CRPV).
* Autonomy, sense of confidentiality and responsibility, open-mindedness and proactivity.
* Excellent interpersonal skills.
* Fluency in English, pharmacovigilance databases and IT is essential.