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Safety Physician

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 www.excelya.com


Position

The Safety Physician (MD) will work with Safety Team, his/her assignments will be:

  • Provide medical review and validation of Individual Case Safety Report
  • Provide medical advice to Safety team on day-to-day aspects ​of Individual Case Safety Report management activities
  • Provide scientific expertise and risk assessment
  • Work cross-functionally to ensure that regulatory objectives are met by reports being submitted according to international regulatory requirements and sponsor objectives and timelines.
  • Deliver efficient and timely review of documentation
  • Miscellaneous tasks



Education and Experience

  • Medical Degree (MD) is mandatory
  • At least 5 years experience as a Drug Safety Physician in a CRO/pharma company (medical device only is not sufficient)
  • Experience in Individual Case Safety Report medical review and validation
  • Significant experience in at least one of therapeutic areas : Oncology or Neurosciences or Rare Disease
  • Strong Knowledge of relevant PV regulations (GVP, ICH, etc.)
  • Proficiency in standardized medical terminology classification (MedDRA)
  • Experience with regulatory reporting tools (EVWeb, FDA, etc.)
  • 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
  • Fluency in English