Medical Safety Reviewer II — Clinical Trial Oversight

Overview

Medical Reviewer/Safety Reviewer II position at Planet Group in Illinois. Target pay range: $29‑39/hr, depending on experience.

Provides timely assessment of reported clinical trial data and participates in safety surveillance activities for assigned studies, including review of labs, vital signs, cardiac, medications, and medical history. Communicates findings to Study Leads.

Reviews safety‑related data from clinical trials for content, quality, identifies potential study‑level trends, and ensures adherence to regulatory guidance and protocols using critical thinking skills.

Monitors safety‑related queries to investigators and adheres to regulatory guidance, protocols, departmental processes, and policies with minimal supervision.

Stays current with ICH, FDA, and EMA regulatory guidance affecting safety surveillance.

• Medical review of Case Report Forms (CRFs), including query resolution and addenda writing.
• Quality Assurance of data listings.
• Manage activities of regional contract CRAs, organize files and budgets for multiple clinical studies.
• Provide medical support: adverse event reporting, investigation and reporting of medical product experiences, and collaboration with Medical Affairs, Clinical, and Regulatory Affairs for FDA documentation.
• Communicate medical/scientific information for complex inquiries beyond the package insert.
• Provide training internally and at investigator meetings on safety issues, serious adverse events, CRF completion, study summaries, and review of protocols, investigator brochures, and IND annual updates.

• Bachelor’s degree with a related health science background.
• RN or clinical pharmacy experience strongly preferred.
• Minimum of 2 years of clinical practice experience; 1 year of drug safety experience preferred.
• Strong critical thinking skills to apply clinical knowledge to adverse event data collection and assessment.
• Ability to present accurate, medically sound safety data orally and in writing.
• Effective communication skills in delivering study‑related information.
• Proficiency with Windows, Word, Excel.

* CO/NYC candidates might not be considered.