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Monday, 10 February 2014

DSP 
ICON Clinical Research - Chennai, Tamil Nadu

Overview of the role - 
  • Review of coding (e.g. MedDRA) and accurate assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events (serious and non-serious) and of Adverse Drug Reactions (serious and non-serious) 
  • Provide support to the Drug Information &Pharmacovigilance Product Support (call) Centre and the related projects, including provision of the Product related information to the callers as well as review and assessment of reported adverse reactions 
  • Review of aggregated reports (e.g. patient profiles, line listings, IND annual reports, Annual Safety Reports, Periodic Safety Update Reports) in terms of Product safety profile 
  • Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and escalate those to the line manager within ICON.

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