Medical Reviewer

Avania; España; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading healthcare company is hiring a Medical Reviewer in Spain to oversee Adverse Events handling and reporting. Candidates should have a nursing background and at least 2 years of clinical research experience. Fluency in English is required, alongside knowledge of FDA regulations and GCP-ICH-E6 standards. Competitive compensation and opportunities for travel are offered, with a hybrid work model possible.

Servicios

Competitive compensation

Opportunities for travel

Hybrid work options

Formación

• 2+ years of relevant work experience in clinical research.
• Ability to understand complex medical details.
• Knowledge of regulatory standards for medical devices.

Responsabilidades

• Oversee the handling of Adverse Events / Serious Adverse Events.
• Review clinical study endpoint events to determine criteria compliance.
• Support liaising with Clinical Events Committees.

Conocimientos

Clinical research experience

Medical knowledge

Understanding of FDA regulations

GCP-ICH-E6 knowledge

Fluent English

Educación

A. / B.S. in nursing or related field

Registered Nurse

Descripción del empleo

Overview

Avania is hiring - Medical Reviewer

We are currently looking at a Medical Reviewer in the EU. Do you want to build your career and be part of a dedicated team? We may be just what you seek!

Responsibilities

The primary responsibility of the Medical Reviewer position is to oversee the handling of Adverse Events / Serious Adverse Events and associated reporting. Additional responsibilities include :

• Review Serious Adverse Events (SAEs), Adverse Events (AEs) and clinical study endpoint events to determine if the events meet pre-defined criteria
• Review of Electronic Case Report Forms (eCRFs), medical information and source documents to develop narratives for the events
• Support and / or act as the liaison to the Clinical Events Committees (CEC), work with the liaison and / or physicians to facilitate the review and adjudication of SAEs and clinical endpoint events
• Provide MedDRA coding of events, if contracted
• In collaboration with Regulatory Lead, assess adverse events for submission to the client and / or regulatory authorities, if contracted
• Review adjudication results to identify any trends that might become apparent
• Review / QC Study Report Tables that present adjudicated data
• Support the DMC liaison as needed, providing information for DMC operation and reporting
• Collaborate on development of safety management plans, safety committee charters, and any additional safety specific related documents that may be required

Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply for Medical Reviewer. With our continued growth we are hiring talent to join us on our journey and grow with us.

Qualifications

• A. / B.S. in nursing or a related medical / healthcare degree or equivalent experience is preferred.
• A Registered Nurse with a strong diverse clinical background or equivalent experience
• Minimum of 2 years relevant work experience in clinical research
• Ability to understand basic and complex medical details
• GCP-ICH-E6, FDA regulations and ISO 14155, 13485 and 9001 knowledge where applicable
• Knowledge of regulatory regulations and guidelines on medical devices
• Fluent English, spoken and written

Benefits

• The opportunity to work in an innovative, fast-growing and rewarding industry
• A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties
• Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities
• Competitive compensation and benefits package (details shared during the interview process)
• Some roles offer the opportunities for travel
• Ask us about our hybrid and fully remote work opportunities

We look forward to receiving your application!

LI-DNI