Clinical Operations

  • location: Cambridge, MA
  • type: Contract
  • salary: $45.27 - $53.26 per hour

job description

Clinical Operations

Drug Safety Specialist

Job Responsibilities

  • Responsible for collecting and processing adverse event reports for clinical trials, compassionate use trials, and marketed products.
  • Assists in the development of safety surveillance processes and writing corresponding SOPs.
  • Assists with other safety surveillance related activities as needed.
  • Receives clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements, obtaining follow up as needed; ensure that all SAEs are complete prior to database closure
  • Process and distributes clinical study SAE reports as per the company SOPs
  • Completes AE/SAE reconciliation prior to clinical trial database closure
  • Receives, processes, and distributes spontaneous adverse event reports for marketed products, both serious and non-serious, as per the company's SOPs
  • Processes all types of adverse event reports utilizing the ARISg safety database
  • Assists with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested
  • Assists with providing safety support and training for clinical, monitoring, and clinical site personnel as needed
  • Assists with implementing safety surveillance processes and establishing appropriate SOPs
Education and Qualifications

  • Bachelors of Science degree in Nursing or Bachelors degree in a specific discipline with clinical experience
  • Minimum of 5 years clinical experience, minimum 3 years pharmaceutical experience with 2 years specific safety surveillance experience
  • Microsoft Windows XP, Microsoft Office Suite, Industry recognized safety database (e.g. ARISg or equivalent)
  • Excellent interpersonal, communication, and writing skills
  • Minimal domestic travel may be required
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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