Safety Reviewer

Highly Competitive Salary
  1. Permanent
  2. Pharmacovigilance, PV Officer/Associate, PV Scientist
  3. United States
North Chicago, USA
Posting date: 26 May 2021

Proclinical is currently recruiting for a Safety Reviewer with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

  • Collects, analyzes and triages adverse events and reviews safety-related data from clinical trials including adverse event reporting
  • medical review including labs, vital signs, cardiac, medical history
  • Participate in safety surveillance activities for assigned products, including assisting with regulatory responses and ad hoc data analysis
  • Creation of narratives of serious adverse events and other identified adverse events of interest in accordance with accepted standards and with minimal revision required upon review.
  • Adherence to regulatory guidance, Protocols, and departmental processes under minimum supervision

Skills and Requirements:

  • Bachelor's degree with related health science background preferred, RN or clinical pharmacy experience strongly preferred.
  • Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered.
  • 2 years clinical experience is required.
  • Competent understanding of ICH/FDA regulations and guidelines affecting drug safety issues.

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.