Medical Safety Reviewer II

The Fountain Group is currently seeking a Medical Safety Reviewer II for a prominent client of ours. This position is Remote. Details for the position are as follows:

Medical Safety Reviewer / Safety Reviewer II
Location: Remote
Pay Rate: $35–$37/hr
Duration: 2-Year Contract (Extension or Conversion Potential)
Shift: Normal Business Hours

Job Description

Seeking a Medical Safety Reviewer to support clinical trial safety surveillance and clinical safety data review across immunology, oncology, and neurology studies. This role requires a minimum of 2 years of hands-on bedside patient care experience, with expertise in reviewing clinical safety data, identifying potential adverse events, and evaluating patient information.

• Review clinical trial safety data through Electronic Data Capture (EDC) systems, including adverse events, laboratory results, vital signs, cardiac data, medications, and medical history.

• Assess adverse event data for clinical significance, accuracy, quality, and potential safety trends.

• Review Case Report Forms (CRFs), resolve data discrepancies, generate queries, and prepare addenda and safety narratives.

• Perform quality assurance reviews of clinical data listings and monitor safety-related investigator queries.

• Identify potential safety signals and communicate findings to Study Leads and clinical safety teams.

• Aggregate and summarize clinical safety data for study presentations and reports.

• Ensure compliance with clinical study protocols, ICH guidelines, and FDA/EMA regulatory requirements.

Education

• Bachelor's degree in Nursing, Pharmacy, or a related healthcare/science discipline required.

• BSN with active RN license strongly preferred.

• PharmD candidates must have hospital or clinical pharmacy experience and appropriate licensure.

• MD/MBBS candidates with at least 2 years of bedside patient care experience may be considered.

• Associate degree-only and LPN candidates are not eligible.

Required Skills

• Minimum 2 years of direct bedside patient care experience; mandatory.

• Active RN or Pharmacist licensure, as applicable to the candidate's clinical background.

• Clinical assessment and critical thinking skills, including evaluation of patient safety data.

• Experience reviewing adverse events, patient medical history, medications, laboratory results, and vital signs.

• Knowledge of clinical trial safety surveillance and clinical data review.

• Working knowledge of ICH, FDA, and EMA safety regulations and clinical study protocols.

• Proficiency in Microsoft Excel and PowerPoint.

• U.S. Citizen or Green Card holder required.

Preferred Skills

• BSN/RN with ICU, ER, emergency medicine, or critical care bedside experience.
• 1+ year of pharmacovigilance (PV), drug safety, or adverse event review experience.
• Pharmaceutical, CRO, or clinical research experience.
• Experience with Medidata Rave, Veeva, or other EDC systems.
• Advanced Excel skills, including VLOOKUPs and pivot tables.
• Experience preparing adverse event narratives, safety summaries, and clinical study reports.
• Experience supporting clinical trials in immunology, oncology, or neurology.

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