Safety Local Manager - Paris, France - Excelya

Excelya

Entreprise vérifiée

Paris, France

il y a 2 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

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:

We propose an exciting mission in an international pharmaceutical environment.

You will be in charge of PV support for local activities including:

Review of product information updates
French HA request
Local risk management plan implementation and other SAF department requests
Safety data analysis for Periodic safety reports (closeout PBRER) or other reports (price and reimbursement file, managed access program dossier)
Monthly safety review for sentinel role and analysis report for off label use.

Minimum Requirements:

Master or Pharmacist degree
Compliance with GVP and GxP environment, background to comply with PV regulations, PV tool (PV database, Meddra)
English environment

Summary: