Medical Reviewer/Safety Reviewer II - Clinical Trial Safety Surveillance & Medical Review

Project overview

Medical Reviewer/Safety Reviewer II - Clinical Trial Safety Surveillance & Medical Review

Responsibilities

• Assess reported clinical-trial data, including laboratory results, vital signs, cardiac data, medications, medical history, and other safety-related information; communicate relevant findings to the Study Lead.
• Review safety-related clinical-trial data for content, quality, potential study-level trends, and adherence to regulatory guidance and study protocols, using strong critical-thinking skills.
• Conduct in-house medical review of Case Report Forms (CRFs), including query resolution, addenda writing, and quality assurance of data listings.
• Monitor and support resolution of safety-related queries issued to investigators.
• Maintain current knowledge of ICH, FDA, and EMA regulatory guidance affecting clinical-trial safety surveillance.
• Investigate and report medical product experiences and adverse events, including in-depth review of medical adverse events and collaboration with Medical Affairs, Clinical, and Regulatory Affairs on documentation prepared for the FDA.
• Provide medical communications support, including standard and customized responses to requests from medical professionals and the public that require complex medical or scientific information, including appropriate dissemination of off-label information.
• Provide training internally and at investigator meetings regarding safety issues, serious adverse events, and CRF completion, as assigned.
• Write study summaries and review protocols, study summaries, investigator brochures, and IND annual updates for safety-data verification.
• May manage activities of regional contract CRAs and organize files and budgets associated with multiple clinical studies.
• Perform responsibilities with minimal supervision while adhering to applicable regulatory guidance, protocols, and departmental processes and policies.

Requirements

People are our business worldwide

Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries.

As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.

• Bachelor's degree with a related health-science background; Registered Nurse or clinical pharmacy experience is strongly preferred.
• Minimum of 2 years of clinical-practice experience is required; at least 1 year of drug-safety experience is preferred.
• Strong critical-thinking skills and the ability to apply clinical knowledge to adverse-event data collection and assessment.
• Ability to present accurate and medically sound safety data both orally and in writing.
• Effective communication skills when delivering study-related information.
• Proficiency with Windows, Microsoft Word, and Microsoft Excel.

Project details

Remote - Candidates have to be located in the US and able to work without visa sponsorship

Length of Assignment: 2 years

$31-37/hr (depending on candidate location and medical benefits preference)

Job Description:

The Medical Reviewer/Safety Reviewer II provides timely clinical and medical review of reported clinical-trial data and participates in safety-surveillance activities for assigned studies. The position evaluates safety data for quality, completeness, potential study-level trends, and adherence to applicable regulatory guidance, protocols, departmental processes, and policies.

• Start: flexible
• Location: United States, Remote work, GB
• Rate: 31-37 EUR/h