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Senior Medical Reviewer

3-4 years
Not Disclosed
10 Nov. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position Title: Senior Medical Reviewer

📍 Location: Mumbai, India
🏢 Department: Clinical
🆔 Job ID: 255628
💼 Employment Type: Full-Time


Job Overview

The Senior Medical Reviewer is responsible for providing expert medical input and review of complex clinical, regulatory, and scientific documents.
This role supports medical writing, medical information services, and safety review activities while ensuring compliance with global regulatory standards. The position also involves training delivery in disease areas and protocol-specific requirements.


Key Responsibilities

1. Medical Review and Input

  • Perform medical data review of laboratory results, adverse events, coding dictionaries, data tables, listings, and figures.

  • Provide medical input and review for moderate to complex clinical and regulatory documents including:

    • Clinical Study Reports (CSRs)

    • Investigator’s Brochures (IBs)

    • Protocols and Product Monographs

    • Clinical & Nonclinical Overviews and Summaries

    • Manuscripts, Abstracts, and Posters

    • Advisory Board Meeting (ABM) Reports

    • Medico-marketing and training materials

    • Aggregate safety reports and signal detection documents (as required)

2. Medical Information Oversight

  • Provide oversight and quality assurance for the company’s Medical Information services.

  • Ensure accurate and compliant communication of medical and product-related information.

3. Training and Knowledge Development

  • Develop and deliver training sessions on disease states, therapeutic areas, and protocol-specific requirements.

  • Participate in internal and external training programs to enhance knowledge of drug development, clinical research, and GCP guidelines.

4. Quality and Process Improvement

  • Identify process gaps or implementation issues in medical and clinical documentation.

  • Provide recommendations and support for remediation and process optimization.

  • Assist in developing and reviewing protocols, case report forms, and project-specific tools.

5. Cross-functional Collaboration

  • Collaborate with Clinical Research, Medical Writing, Regulatory Affairs, and Pharmacovigilance teams.

  • Contribute medical expertise across multidisciplinary project teams.


Qualifications

Education

  • MBBS or MD with relevant clinical experience.

  • Equivalent or relevant experience may be considered in lieu of formal qualification.


Experience Requirements

Requirement

Description

Experience Level

Minimum 3–4 years in pharmaceutical industry or CRO

Functional Areas

Clinical Research, Medical Services, or Medical Writing (including Medical Communications)

Document Experience

Authoring/reviewing complex clinical documents such as CSRs, IBs, Protocols, Clinical Overviews/Summaries, Product Monographs, Publications

Knowledge Areas

Therapeutic area expertise, drug development lifecycle, clinical and safety data evaluation

Regulatory Knowledge

Strong understanding of ICH-GCP, clinical trial reporting, and publication standards


Core Skills and Competencies

  • Excellent analytical and critical thinking skills to interpret clinical and preclinical data.

  • In-depth understanding of regulatory document structures and content requirements.

  • Strong command of medical and scientific terminology.

  • Proficiency in MS Office Suite (Word, Excel, PowerPoint).

  • Outstanding written and verbal communication abilities.

  • Strong collaboration, leadership, and mentoring skills.


Work Environment

  • Location: Mumbai, India

  • Travel: Required (as per business needs)

  • Work Mode: Office-based / Hybrid

  • Physical Demands: Standard professional office activities


Equal Opportunity Statement

Fortrea is an Equal Opportunity Employer. We embrace diversity and inclusion in all employment practices and provide reasonable accommodations upon request.

Learn more about our EEO & Accommodations policies here.