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Safety Officer

2 months ago

bangalore, India Excelya Full time

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