Clinical Operations

  • location: North Chicago, IL
  • type: Contract
  • salary: $40 - $50 per hour

description

Chat with me now! - https://flashrecruit.com/jobs/296479

Job Title: Medical Reviewer/Safety Reviewer - C

Position Responsibilities

  • Reviews safety-related data from clinical trials for content, quality, adherence to regulatory guidance and protocols.
  • Triages SAE information in order to fulfill timely reporting according to the authority/regulatory requirements.
  • Participates in applicable safety surveillance activities for assigned products.
  • Collects, analyzes, and triages AEs including reporting SAEs to IND safety.
  • Assessment of AE coding for consistency and accuracy of coding.
  • Medical review of safety-related CRFs and labs, including communication with Study Physicians.
  • Interface with study manager, CROs, CRAs, Data Management, PV to assure query resolution.
  • Creation of narratives of SAEs and other identified AEs of interest in accordance with accepted standards and with minimal revision required upon review.

Position Requirements

  • Pharma experience is required.
  • MUST BE AN RN.
  • Broader knowledge of ICH/FDA regulations and guidelines affecting drug safety issues preferred.
  • Computer proficient (Windows, Word, Excel).
  • Able to present adverse event data, orally and in writing

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Chat with me now! - https://flashrecruit.com/jobs/296479

get jobs in your inbox.

sign up
{{returnMsg}}

related jobs

    Clinical Operations

  • location: North Chicago, IL
  • job type: Contract
  • salary: 40 - 47.52 per hour
  • date posted: 1/29/2018

    Regulatory

  • location: North Chicago, IL
  • job type: Contract
  • salary: 33.99 - 39.99 per hour
  • date posted: 1/26/2018

    Clinical Operations

  • location: North Chicago, IL
  • job type: Contract
  • salary: 19 - 23.30 per hour
  • date posted: 1/31/2018