Drug Safety Specialist in Cambridge, MA at Apex Life Sciences

Date Posted: 3/14/2018

Job Snapshot

Job Description

  • Principal Objective(s):
    • 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.
  • Major Duties and Responsibilities:
    • 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 SOP’s
    • 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 Experience
  • Requirement:
    • Minimum of 5 years clinical experience, minimum 3 years pharmaceutical experience with 2 years specific safety surveillance experience
  • Skills:
    • Microsoft Windows XP, Microsoft Office Suite, Industry recognized safety database (e.g. ARISg or equivalent) Excellent interpersonal, communication, and writing skills
  • Education:
    • Bachelor's of Science degree in Nursing or Bachelor's degree in a specific discipline with clinical experience

Minimal domestic travel may be required

Please email: mmiller@apexlifesciences.com for consideration.