Lead Medical Reviewer

Navitas Life Sciences Pvt. Ltd.; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Navitas Life Sciences Pvt. Ltd. seeks an experienced Lead Medical Reviewer with 3–4 years of clinical trial experience and deep expertise in medical and safety review across oncology, immunology, gene therapy, and other specialties.

The role centers on medical review of SAEs/SUSARs, signal detection, and collaboration with cross-functional clinical and regulatory teams. The successful candidate will lead safety assessments, prepare global/regional RMPs, and contribute to safety sections of

Qualifications

• MBBS and/or MD from a recognized institution.
• Minimum 3-4 years of clinical trial experience focused on medical review and drug safety.

Responsibilities

• Review SAEs/SUSARs and other safety reports for medical accuracy.
• Lead safety signal assessment and monitoring.
• Prepare/review global/regional Risk Management Plans (RMPs).
• Author/review safety sections in aggregate safety reports.
• Provide medical input into protocols, SAPs, CSRs, and related documents.
• Contribute to safety content for regulatory submissions (NDAs, etc.).
• Assess safety data and dose-limiting toxicities (DLTs) and benefit-risk.
• Support analysis/interpretation of trial outcomes.
• Develop/review study documents (IBs, ICFs, REMS, SAPs, CSRs).
• Respond to regulators, ethics committees, and IRBs during audits/requests.
• Chair or support Medical Surveillance Teams (MSTs).

Skills

Medical review

Safety review

Signal detection

Regulatory submissions

Clinical data interpretation

Education

MBBS and/or MD

Job description

We are seeking an experienced Lead Medical Reviewer with 3-4 years of clinical trial experience and strong expertise in medical and safety review activities. Experience across therapeutic areas such as Oncology, Immunology, Gene Therapy, and other specialty indications is highly preferred. The ideal candidate will have hands-on experience in safety data assessment, medical review, signal detection, and close collaboration with cross-functional clinical and regulatory teams.

Key Responsibilities

• Conduct medical review of SAEs, SUSARs, and other safety reports to ensure medical accuracy and completeness.
• Evaluate and validate emerging safety signals and lead comprehensive signal assessment activities.
• Prepare and review global and regional Risk Management Plans (RMPs), including additional risk minimization strategies.
• Author and review safety sections of periodic aggregate safety reports.
• Provide medical and safety input into clinical documents, including study protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs).
• Contribute to the preparation and review of safety-related content for regulatory submissions, including NDAs and other health authority filings.
• Perform ongoing review and interpretation of clinical safety data, including assessment of Dose-Limiting Toxicities (DLTs) and benefit-risk profiles.
• Support analysis and interpretation of clinical trial outcomes.
• Assist in the development, review, and finalization of study-related documents such as DSMB Charters, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), REMS, RMPs, SAPs, CSRs, and health authority reports.
• Support responses to regulatory agencies, ethics committees, and institutional review boards during audits, inspections, and information requests.
• Chair or support Medical Surveillance Teams (MSTs) in monitoring and evaluating safety data throughout the clinical development lifecycle.

Qualifications

• MBBS and/or MD from a recognized institution.
• Minimum of 3-4 years of clinical trial experience with a focus on medical review and drug safety.

Equal Opportunity Statement

We are an equal opportunity employer and are committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic under applicable law