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Case Evaluator job in Budapest at TATA Consultancy Services - Hungary

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Case Evaluator at TATA Consultancy Services - Hungary

Case Evaluator

TATA Consultancy Services - Hungary Budapest, HU Full Time
Required languages: English (Business Fluent)
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Do you have a medical doctor degree? Are you looking for full-time job? Are you interested in being a part of the our Pharmacovigilance team and play a key role in ensuring that drugs on the market are safe for use?


If you are, read on, we have a great opportunity for you to support one of the world's most prestigious pharma companies as Case Evaluator. You will be part of a 100+ multicultural team, working to help create a new drug that helps humankind live freely.

HOW WILL YOU MAKE AN IMPACT?

  • Diligent evaluation and assessment of complex reports from clinical development projects as well as post marketing cases. Reporting sources include medical literature as well as from post marketing surveillance studies.
  • Ensure high medical quality and compliance with all health authority requirements regarding AE/ADR single case handling.’
  • Ensure medical plausibility, consistency and completeness of SADR case reports.
  • Request follow-up information, and initiate use of specific product/event-related questionnaires when necessary
  • Confirm determination of seriousness, assess drug product causal association and assign global labeling status (expected or unexpected) in order to achieve the appropriate case reporting status for global distribution for regulatory agency reporting. Consult medical experts within TA group for advice in complex clinical questions.
  • Medical coding of various case data including all AE and Drug terms. This requires in depth of the present coding systems (MedDRA and WHO-DD) with respect to structure and medical content.
  • Create written company causality comment for ADR case reports in accordance with internal standards and guidelines.
  • Verification of SAE case evaluation within area of responsibility for conformity with internal SOPs and operational manuals.

ARE YOU A GOOD FIT?

  • Academic Qualification: Medical Doctor Degree
  • Computer Literate ( good knowledge of MS Office)
  • Sound understanding of the Drug Safety and Regulatory process.
  • 0 to 2 years in case processing/ Pharmacovigilance is preferred

WHAT DO WE OFFER?


In our organization, you can taste the world by working together with more than 90 nationalities. As part of the Tata Group, India’s largest multinational business group, TCS has over 450,000 of the world’s best-trained consultants in 46 countries.


This position belongs to the BPS Lifesciences (Business Process Solutions) unit. This unit is helping enterprises achieve significant and sustained business outcomes by leveraging our deep domain expertise and operations. We support our Pharmaceutical customers in Pharmacovigilance, Regulatory affairs, Clinical Data Management, and other aspects of clinical research. As a future TCSer, you will be provided with:

  • A career path
  • A great diversity of cultures
  • Language courses and training
  • On-site relax & gym rooms
  • Volunteering, sport and employee events

Recommended Skills

Clinical Research
Pharmacovigilance
Pre Clinical Development
Clinical Data Management
Med Dra
Operations

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