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Safety Specialist

2 months ago

Bengaluru, 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


Position:

The Safety Specialist is responsible for the handling cases and back office performance.

  • Operational support to the case processing team for Individual Case Safety Report management activities​
  • Manage activities perform by the Back Office​
  • KPI update​
  • Escalation management with Front Office


Education and Experience

  • At least 4-5 years of previous working experience in PV
  • 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 quality review of ICSRs
  • Experience in ArisG System
  • Fluency in English