Safety Officer

Excelya

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.

To learn more about us, visit www.excelya.com

The Position

The Safety Officer (SO) is responsible for the handling cases and reconciliation in PV.

Individual Case Safety Report operational management (all case type)

Reconciliation with affiliates, vendors, commercial partners, medical affairs...

Operational Case Transfer and migration

Global and local literature screening / review

Miscellaneous tasks

Support to regional safety teams

Education and Experience

At least 2 years of previous working experience in Pharmacovigilance

Strong Knowledge of relevant PV regulations (GVP, ICH, etc.)

Experience with PV systems (safety databases)

Proficiency in standardized medical terminology classification (MedDRA)

Experience with regulatory reporting tools (EVWeb, FDA, etc.)

Narrative writing ability - written communication skills

Attention to Detail

Familiarity with Microsoft Office & DMS (SharePoints)

Time management & Organizational skills

Ability to analyze & assess safety data -analytical skills

Able to work both independently and within teams - team player

Strong sense of ethical responsibility and confidentiality

Experience in ArisG System

Fluency in English