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.
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