Clinical Safety Specialist
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Clinical Safety Specialist
Ref No.: 18-26077
Location: Irvine, California
Start Date / End Date: 06/04/2018 to 06/04/2019
Company: Artech Information Systems
Job Title: Clinical Safety Specialist
Job ID: 18-26077
Location: Irvine, CA
Duration: 12+ Months
Position Summary
The Clinical Safety Specialist will work with other members of the Clinical Safety team, Clinical Operations, Data Management, Quality Assurance and Regulatory Affairs to manage death and adverse event reporting in compliance with applicable regulatory standards and Client internal requirements
Principal Accountabilities
  • Review and triaging clinical trial deaths and adverse events (AEs) including serious adverse events (SAEs).
  • Conduct Case Management in the Clinical Safety Database.
  • Interacts with investigational sites and field monitors to obtain additional pertinent information as indicated.
  • Works with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events (e.g., SAEs , adverse events (AEs), and device deficiencies).
  • Works with Regulatory Affairs, Clinical Operations and Clinical Quality to ensure timely reporting of AEs, SAEs and UADEs including expedited and annual reporting and other documents as needed.
  • Ensures appropriate distribution and notification of SAEs and UADEs to appropriate personnel, partners, and clinical centers for protocol(s).
  • Liaison for safety-related questions ( e.g., to study team, field support, monitors, and study sites)
  • Write Clinical Safety Management Plan for assigned protocol(s).
  • Write safety narratives
  • Assists with preparation of assigned section of safety reports for annual reports, clinical study reports, investigator brochure updates, and other documents as required.
  • Collaborates with data management and other departments on the development of case report forms, study specific safety reports, and other study specific forms.
  • Assists with the writing of safety sections of clinical protocols and may present safety monitoring at investigator meetings.
  • Performs other duties as assigned.
  • Bachelor’s degree
  • 4 years Safety Experience, or
  • 2 years in Clinical Safety and 2 years of Clinical Experience
Desired/Preferred Qualifications
  • RN, or allied health professional
  • Safety experience in the pharmaceutical or medical device industries
  • Thorough understanding of the general clinical research process with broad knowledge of GCP reporting guidelines, regulatory agency (US and OUS as is appropriate) regulations
  • Broad medical knowledge capable of supporting the safety needs
  • Good written, oral, and interpersonal communication skills
  • Knowledge of medical terminology.
  • Proficient with MS Office products, word processing, spreadsheets, etc.
  • High attention to detail and accuracy and ability to manage multiple tasks.
Rajiv Maruthi