Medical review of adverse events (including identification of event/s, confirmation of seriousness, verifying MedDRA & WHO drug coding and labeling, reviewing narratives and causality assessments)
Provide assessment of expectedness per reference safety information
Ensure compliance with respect to evaluation, reporting, and surveillance of safety information
Interact with clients safety/medical personnel as per the requirement
Serve as a mentor for other internal safety staff including case processing staff
0-2 years of experience in clinical practice is desirable, but not mandatory
Knowledge of global pharmacological regulations
Excellent command over English language (written and verbal)
Decent knowledge of ICH guidelines and regulations relating to safety reporting.
About Crest Premedia
Crest is a hundred percent export unit, based in Pune and is part of... Springer Science + Business Media, Germany. The company is in the area of Software Development, Print and Electronic typesetting, marketing services and back office operation.
Crest Premedia, was born in 2006 and earned its stripes working on projects for Springer. In doing so, Crest has innovated and broken language frontiers in premedia by acquiring skills in German and Dutch language. Today Crest offers these and more innovative services in areas of STM books, Journals, eBooks, ePubs, PowerPoint reports, marketing services, technical and customer support.
Please visit www.crest-premedia.in and www.springer.com for further information about our organization.
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