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:
Coordinate signal detection activities for compounds under development and commercialized:
* request data from contributors,
* evaluate safety data,
* analyze and interpret case series or data sets by initiating database searches,
* analyze data, complete and write sections of signal detection reports (SER, DSER),
* create or update appendices (SER, DSER), perform quality control.
* Contribute to the review of pharmacovigilance cases (narrative, scoring, company comment, coding, consistency, etc.) concerning the products in his/her portfolio documents concerning the products in its portfolio: 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 methods.
* Represent PEX in all clinical trial-related tasks
* Preparatory meetings prior to implementation (e.g. contribution to the drafting of documents prior to implementation), follow-up phase (e.g. IME upgrade meetings, reconciliation), results exploitation phase with safety analysis.
* Coordinate the drafting of safety reports: SERs, DSURs, PSURs, Clinical Overviews, ad hoc expert reports, answers to questions from authorities and subsidiaries, PV surveys, or any safety data analysis document.
* Carry out monthly quality control of adverse effects or events relating to the use of products in its portfolio. Medical review of cases includes validation and consistency of narratives, coding and scoring of events.
* Reconciles PV cases exchanged with partners or subsidiaries.
* Lead the Safety Team and take part in project team meetings (Core Team, Study Team, Clinical Team) concerning its products. Act as the main point of contact for internal and external collaborators (service providers, partners, LPV, experts, etc.) for all questions relating to the safe use of the product(s) for which he/she is responsible, and contribute to the development of new safety studies.
* Coordinate the drafting of risk management plans (RMPs) for the products for which he/she is responsible.
Minimum Requirements :
Doctor’s diploma with at least 8 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