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Medical Reviewer/Safety Reviewer - B

Abbott Park, ILRandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/300377

Job Title:  Medical Reviewer/Safety Reviewer - B

Position Responsibilities

  • Reviews safety-related data from clinical trials for content, quality, adherence to regulatory guidance and protocols.
  • Reviews and follows-up on Serious Adverse Event (SAE) information in order to fulfill timely reporting according to the authority/regulatory requirements.
  • Participates in applicable safety surveillance activities for assigned products.
  • Reviews and analyzes Adverse Events (AE) including SAEs being reported to IND safety.
  • May include assessment of AE coding for consistency and accuracy of coding.
  • Medical review of safety-related Clinical Report Forms and labs, including communication with Study Physicians. Interface with study manager, CROs, CRAs, Data Management, PV to assure query resolution.
  • Creation of narratives for SAEs and other identified AEs of interest in accordance with accepted standards and with minimal revision required upon review.

Position Requirements

  • MUST be medically trained, RN preferred, but will consider MD or Pharm D (with hospital experience .
  • Therapeutic Areas are Oncology and Immunology. Experience in either of these areas is helpful.
  • 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/300377