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:
Contribute to signal detection activities for compounds under development and marketed:
* Initiate, prepare and if necessary coordinate signal detection,
* Request data from contributors,
* Create queries in the pharmacovigilance database to generate line-listings and summary tables,
* Analyze data, complete and write sections of signal detection reports (Safety Evaluation Report (SER), Development Safety Evaluation Report (DSER)),
* Create or update appendices to the above-mentioned documents, perform quality control.
Contribute to the preparation of all pharmacovigilance deliverables:
* Initiate, prepare and if necessary coordinate, contribute to data analysis and the drafting of aggregate safety reports (PSURs, PBRERs, DSURs, RMPs, PADERs, Clinical Overviews, Annual Safety Reports, Answers to questions from authorities and subsidiaries, PV surveys, or any safety data analysis document),
* Contribute to the proofreading of documents concerning the portfolio’s products: investigator’s brochure, patient consent and information, study report and reference documents, safety sections of interventional and non-interventional clinical study protocols, particularly those describing safety data collection and reporting procedures.
* Carry out monthly quality control of adverse effects or events relating to the use of products in the portfolio. Medical review of cases includes validation and consistency of narratives, coding and scoring of events.
* Reconcile PV cases exchanged with partners, subsidiaries or the data management department (for clinical studies).
* Prepare lists of codes corresponding to CCDS/ CCSI/ RSI/ IB or local PI and monitor their validation and finalization.
Minimum Requirements :
Doctor of Pharmacy with at least 3 years’ experience in a similar position in the pharmaceutical industry.
You have a team spirit, good interpersonal skills and are autonomous.
The position is based in Paris Area