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Posted 100 months ago

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Drug Safety Coordinator

Foster City, CA, United StatesRemoteFull-time

AI Summary

Coordinates drug safety activities, reviews and enters adverse event (AE) and SAE data from ICSR and clinical trial reports, and ensures data accuracy and regulatory compliance.

About this role

Drug Safety Coordinator

Alois was founded on the value of respect for everyone as individuals, irrespective of their backgrounds. We embrace all our people’s differences – be it working/thinking styles, capabilities, preferences, needs OR age, gender, ethnicity, nationality, and religion. We value the richness and variety of ideas and approaches that result from these differences and constantly work towards the betterment of people and the firm.

  • Excellent interepersonal communication skills, both written and oral
  • Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word)
  • Safety database and data entry experience preferred
  • Basic understanding of medical and drug terminology preferred
  • Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
  • Demontrates initiative, teamwork and accountability
  • Demonstrated success working both independently and in collaboration with others
  • A quality driven individual with strong attention to detail and accuracy is required
  • Strong organizational skills, and ability to adapt to change
  • A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strick timelines is required
  • Ability to follow guidelines and procedural documents Operations Sets work priorities and direction with input from Manager
  • Review, extract and accurately enter AE data from ICSR reports from both investigational and postmarketing products
  • Have solid working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports
  • Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate

Additional Information

All your information will be kept confidential according to EEO guidelines.

Skills

Adverse Event ReportingData EntryICSRMicrosoft ExcelMicrosoft PowerPointMicrosoft WordProtocol DesignRegulatory ComplianceSAESafety Database

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