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