Medical Reviewer
A Medical Reviewer plays a critical role in ensuring the accuracy, completeness, and compliance of medical information within the healthcare and pharmaceutical industries. Their responsibilities can vary depending on the specific employer and the area of focus (e.g., clinical trials, pharmacovigilance, medical records, healthcare compliance). However, some common elements appear in most job descriptions for this role:
Core Responsibilities
Review and Analysis of Medical Documents: This is a primary function, involving the meticulous examination of various medical documents such as:
- Clinical trial data (case report forms, study reports, safety data).
- Individual Case Safety Reports (ICSRs) and adverse event reports.
- Medical records and patient charts.
- Insurance claims and pre-authorization requests.
- Regulatory documents and submissions.
- Marketing and promotional materials.
Evaluation of Medical Content: Assessing the accuracy, completeness, consistency, and scientific validity of the information presented in medical documents.
Ensuring Regulatory Compliance: Verifying that medical activities and documentation adhere to relevant regulations, guidelines (e.g., GCP, ICH, FDA), and internal standard operating procedures (SOPs).
Identifying and Resolving Discrepancies: Detecting errors, inconsistencies, and missing information within medical documents and working to clarify or resolve these issues, often by communicating with study sites, healthcare professionals, or other relevant parties.
Providing Medical Expertise and Input: Offering expert opinions and recommendations on medical issues, safety concerns, and the interpretation of medical data.
Generating Reports and Providing Feedback: Preparing detailed reports summarizing findings, highlighting areas of concern, and providing constructive feedback to relevant teams or individuals.
Collaboration with Multidisciplinary Teams: Working closely with data managers, trial managers, medical writers, safety scientists, regulatory affairs specialists, and other healthcare professionals.
Maintaining Knowledge of Medical Advancements and Regulations: Staying up-to-date on the latest medical literature, treatment guidelines, and regulatory changes.
Contributing to Process Improvement: Identifying opportunities to enhance the efficiency and quality of medical review processes.
Training and Mentoring (for more senior roles): Providing guidance and training to junior team members.
Common Requirements and Skills
- Medical Degree: Typically, an MBBS, MD, BDS, PharmD, or equivalent advanced degree in a relevant healthcare or life sciences field.
- Clinical Experience: Often, prior experience in clinical practice or clinical research is required.
- Knowledge of Medical Terminology and Coding Systems: A strong understanding of medical terminology, anatomy, physiology, pharmacology, and potentially medical coding (e.g., ICD, CPT).
- Understanding of Regulatory Guidelines: Familiarity with Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and other relevant regulatory requirements.
- Analytical and Problem-Solving Skills: Ability to critically evaluate complex medical information and identify and resolve issues.
- Attention to Detail: Meticulous and thorough reviewing documents to ensure accuracy and completeness.
- Communication Skills: Excellent written and verbal communication skills for preparing reports, providing feedback, and collaborating with others.
- Computer Proficiency: Familiarity with MS Office Suite and potentially other relevant software and databases.
- Organizational and Time Management Skills: Ability to manage multiple tasks, prioritize effectively, and meet deadlines.
- Teamwork and Interpersonal Skills: Ability to work effectively within a team and build positive working relationships.
Depending on the specific role and company, additional requirements or preferred skills might include:
- Experience in a specific therapeutic area.
- Pharmacovigilance experience for drug safety roles.
- Experience with electronic data capture (EDC) systems.
- Project management skills.
- Fluency in multiple languages.
- Relevant certifications (e.g., Certified Professional Medical Auditor).