Medical Reviewer

Tata Consultancy Services; Maharashtra; On-site; INR 500,000 - 800,000; Full time

Job summary

A leading IT services company based in India is seeking a Medical Reviewer to handle the medical review and assessments of clinical cases. This full-time associate role involves ensuring compliance with regulations, supporting drug safety teams, and representing the safety physician team in safety forums. Candidates should have strong attention to detail and knowledge of clinical assessments. Interested applicants can send their CV to the provided contact email.

Qualifications

• Accountable for the medical review of relevant clinical cases and medical assessments.
• Develop and maintain knowledge of disease biology areas and safety concerns.
• Support Drug Safety teams in quality of adverse event data processing.

Responsibilities

• Ensure compliance with regulatory and client policies.
• Represent the safety physician team in safety forums.
• Generate and track medically relevant queries.

Skills

Medical review

Regulatory compliance

Knowledge of clinical assessments

Safety reporting

Strong attention to detail

Job description

Medical Reviewer – Tata Consultancy Services

Domain: Life Sciences

Responsibilities

• Accountable for the medical review of relevant clinical, other solicited and spontaneous cases (including literature articles) and medical assessment (including labeling and causality along with the company causality statement).
• Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history.
• Develop and maintain thorough knowledge of the appropriate disease biology areas and important safety concerns for marketed drugs and drugs in development.
• Assure and maintain compliance with regulatory and local/global SOP timelines.
• Support the Drug Safety teams with medical concepts and awareness of product‑related topics to ensure quality of adverse event data processing.
• Represent the safety physician team in internal and client safety forums and audits.
• Review and respond to any queries/comments for an individual case safety report in the Patient Safety database.
• Generate, send, and track medically relevant queries for follow‑up information required for an individual case safety report.
• Provide product advice as required, especially regarding case reports that are Suspected Unexpected Serious Adverse reactions (SUSAR).
• Ensure compliance with global and local procedural documents and implementation of client and TCS policies, procedures, and processes.

Seniority Level

• Associate

Employment Type

• Full‑time

Job Function

• Health Care Provider and Science

Industries

• Hospitals and Health Care

Contact

Interested candidates are requested to share updated CV with [e-mail]