Drug Safety Specialist

  • location: Cambridge, MA
  • type: Contract
  • salary: $46.15 - $54.29 per hour
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job description

Drug Safety Specialist

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

location: Cambridge, Massachusetts
job type: Contract
salary: $46.15 - 54.29 per hour
work hours: 9 to 5
education: Bachelors
  • 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
  • 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
skills: SOP, ARISg, Drug Safety, SAE (Serious Adverse Event), AD (Adverse Events)
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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