Contribute to triage for respective cases
Contribute in the triage and assessment of worldwide cases, as necessary
Provide good quality medical review of adverse events reports for the responsible products and of adverse events reports for other products as needed
Checking for correctness of adverse event/case labeling and causal relationship, association of diagnosis and signs/symptoms and providing medical comments, as appropriate
Clarify complex medical information and provide consultation on coding issues for DS Coding Specialists and DS Scientists
Perform follow-up as applicable, contact the reporter as appropriate for clarification, Identification of missing information/inconsistencies and completion of Data Clarification Forms via SmartTrack
Perform analysis of similar events’ for suspected unexpected serious adverse reaction cases and review periodic serious adverse reaction cases listings
Review medical literature for the responsible product
Preferably international experience in the Drug Safety environment of pharmaceutical industry and in collecting, analysing, assessing and reporting adverse events associated with investigational and marketed products
Doctor of Medicine degree with license
Knowledge of international safety regulations
Strong verbal and written English communication skills
Projektdauer: 12 MM+
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