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Medical Reviewer

2-5 years
Not Disclosed
10 Nov. 11, 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

Medical Reviewer

Location: Mumbai
Experience Required: 2–5 years
Minimum Qualification: MBBS / MD
Job ID: 379725
Function: Business Process Services
Role: Executive


Role Overview

The Medical Reviewer is responsible for clinical and safety evaluation of solicited, unsolicited, and literature cases, ensuring accurate medical assessment, regulatory compliance, and high-quality adverse event data processing.


Key Responsibilities

1. Case Review & Medical Assessment

  • Perform medical review of clinical, solicited, and spontaneous cases, including literature reports.

  • Assess seriousness, causality, labeling, and apply company causality statements.

  • Review narratives, AE/SAE terms, suspect drugs, concomitant medications, labs, and patient history.

  • Evaluate global medical context for the drug or clinical project.

2. Safety Expertise & Disease Knowledge

  • Maintain strong understanding of disease biology and safety concerns for marketed and developmental drugs.

  • Provide medical insights to Drug Safety teams for high-quality case processing.

  • Offer product advice, especially for SUSAR (Suspected Unexpected Serious Adverse Reaction) cases.

3. Compliance & Regulatory Support

  • Ensure adherence to global and local SOPs, regulatory timelines, and compliance standards.

  • Support internal and client audits by representing the safety physician team.

  • Ensure implementation of client and TCS policies, procedures, and processes.

4. Query Management & Communication

  • Review and respond to safety database queries/comments on individual case safety reports (ICSRs).

  • Generate, send, and track medically relevant follow-up queries for ICSRs.

  • Communicate effectively with cross-functional teams to ensure case quality and completeness.


Skills & Competencies

  • Strong medical knowledge with practical application in drug safety

  • Understanding of Drug Safety, Regulatory Processes, and Pharmacovigilance workflows

  • Computer literacy (MS Office, safety databases preferred)

  • Self-directed learning ability

  • Effective problem-solving and decision-making skills

  • Excellent communication and interpersonal skills

  • Ability to prioritize, plan, and work independently

  • Team player with ability to collaborate across multidisciplinary teams


Desired Candidate Profile

  • Qualifications: MBBS or MD

  • Strong medical understanding, safety assessment capability, and decision-making skills

  • Ability to work in safety operations environment with high accuracy and compliance focus