A growing pharmaceutical is looking for a Drug Safety Specialist to provide support as a member of the Safety Operations team within Global Pharma. May perform initial triage of source documents for duplicate check within the Global Safety Database, case priority, Awareness Date, and closure/submission timeline.
Review source documents for accuracy of triage assessment to include case priority, Awareness Date and internal and external completion/submission dates
Perform initial safety review of adverse events to determine seriousness, expectedness, reporter’s causality, and overall event resolution.
Ensure that the correct suspect drug was selected within the GSD
Write summaries all relevant medical information for individual case safety reports
Interface with other groups (e.g. Quality, Regulatory, IT, Legal, business units, etc)
Preferred candidates will have the following:
BS in biology, Health sciences, Nursing or other related sciences
Demonstrated experience in Pharmaceutical industry