Medical Data Reviewer

IQVIA; Bengaluru; On-site; INR 600,000 - 850,000; Full time

Job summary

IQVIA is seeking a Medical Data Reviewer to validate structured clinical patient data for plausibility and protocol adherence. You will determine completeness and readiness of information for next review stages while coordinating with clinical sites and the medical review team.

The role focuses on data quality, review of AEs, lab results, and EOS documentation, with emphasis on cross-functional collaboration and timely issue resolution.

Qualifications

• BDS/MDS with 2 years of work experience.
• Understanding of clinical/medical data.
• Background in Medical Terminology, Pharmacology, Anatomy, and Physiology.
• Excellent motivational, influencing and coaching skills.
• Ability to work on multiple projects and manage competing priorities.
• Strong customer focus and ability to build relationships with coworkers, managers and clients.

Responsibilities

• Identify anomalies in patient data requiring site follow-up to ensure accuracy.
• Review investigation product dosing records for protocol adherence and dose accuracy.
• Review all reported AEs to verify supporting information and data plausibility.
• Review all reported Concomitant Medications for protocol alignment and relevance to AEs.
• Review inclusion/exclusion criteria to confirm patient eligibility for the trial.
• Ensure EOS information is properly documented to determine reason for study participation.
• Review laboratory results for completeness and safety signals not documented in AE.
• Review patient medical history for completeness and protocol alignment.
• Review additional information to determine readiness of data for next review stage.
• Review Line Listings for data accuracy across patients.
• Review status information and data flow reports; take appropriate actions.
• Serve as POC/Back-up POC and liaise with medical review staff and clients.
• Attend Kick-Off, weekly team, and client meetings as needed.

Skills

Clinical data understanding

Medical terminology

Pharmacology

Anatomy

Physiology

Coaching skills

Multi-project management

Customer focus

Relationship building

Education

BDS/MDS with 2 years of work experience

Job description

Medical Data Reviewer Job Overview

Review structured clinical patient data output without direct access to medical charts to ensure medical plausibility and to determine adherence to protocol and overall completeness and readiness of the supplied patient information for next level of review.

Essential Functions

• Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy
• Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages
• Review all reported Adverse Events (AEs) to ensure all supporting information is expected and/or implausible data is verified.
• Review all reported Concomitant Medications to ensure no medication is disallowed per protocol, supports an existing reported medical condition or is prescribed for a reported AE
• Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial
• Ensure proper end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending participation in the clinical trial
• Review all laboratory results to ensure completeness of information supplied, adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient
• Review all patient reported medical history information to verify completeness of reported information, adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
• Review additional information, as necessary, to determine overall readiness of the patient information for next level review
• Review all supplied Line Listings to determine data accuracy across patients within a specified group of data points
• Review status information and data flow reports and take appropriate actions
• Serve as POC/ Back-up POC
• Interact with other Medical review staff to verify/clarify information and/or triage new data issues or prior identified action items
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.

Qualifications

• BDS/MDS with 2 years of work experience
• Understanding of clinical/medical data.
• Background in Medical Terminology, Pharmacology, Anatomy, and Physiology
• Excellent motivational, influencing and coaching skills
• Ability to work on multiple projects and manage competing priorities
• Strong customer focus skillsAbility to establish and maintain effective working relationships with coworkers, managers and clients

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Experience Level Mid Level