Instagram
youtube
Facebook

Senior Medical Reviewer

3-4 years
Not Disclosed
10 Nov. 17, 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

Senior Medical Reviewer – Fortrea

Location: Mumbai
Category: Clinical
Job ID: 255628


📌 Job Overview

The Senior Medical Reviewer provides medical expertise and conducts medical review for a wide range of moderate to complex clinical and regulatory documents such as:

  • Manuscripts, abstracts, posters

  • Advisory Board Meeting (ABM) reports

  • Clinical Study Reports (CSRs)

  • Clinical & Nonclinical Overviews and Summaries

  • Investigator’s Brochure (IB)

  • Protocols & Product Monographs

  • Medico-marketing & training materials

  • Safety documents: aggregate safety reports, signal detection

  • Oversight of medical information services

The role also involves delivering training on disease areas and protocol-specific requirements.


🧪 Key Responsibilities

Medical Review & Clinical Support

  • Conduct medical data review: lab values, AEs, coding dictionaries, tables, listings, figures.

  • Provide medical input to complex clinical and regulatory documents (CSRs, IBs, protocols, summaries, publications, product monographs).

  • Review safety documents (aggregate reports, signal detection) when required.

  • Assist in development and review of:

    • Protocols

    • Case Report Forms (CRFs)

    • Project tools

    • Clinical trial reports

Medical Information & Training

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

  • Deliver training on disease states, clinical research processes, and protocol requirements.

  • Participate in continuous learning for drug development and GCP guidelines.

Process Improvement

  • Identify process gaps and propose corrective actions.

  • Support remediation activities where needed.


🎓 Qualifications (Minimum Required)

  • MBBS or MD with clinical experience.

  • Equivalent relevant experience may be considered.


💼 Experience Required

  • 3–4 years in the pharmaceutical industry/CRO in:

    • Clinical research

    • Medical services

    • Medical writing/medical communications

  • Experience in writing or reviewing complex clinical documents (CSRs, IBs, protocols, summaries, publications).

  • Strong understanding of:

    • Therapeutic areas

    • Preclinical, clinical & safety data evaluation

    • ICH and regulatory guidelines for drug development and clinical reporting


🛠 Skills Required

  • Excellent written & verbal communication

  • Strong analytical and critical discussion skills

  • Advanced knowledge of regulatory expectations

  • Proficiency in MS Office


🌍 Work Environment

  • Travel required.


About Fortrea

Fortrea is a global CRO operating in ~100 countries, offering solutions across 20+ therapeutic areas. The organization focuses on scientific rigor, innovation, and accelerating the development of life-changing therapies.

Culture Values – Fortrea FOUR:

  • Forward Together

  • Own It

  • Uphold Integrity

  • Respect People

Visit: fortrea.com for more information.