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1-5 years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Job Title: Medical Reviewer

Location: Mumbai

Experience Range: 9 months to 4 years in Pharmacovigilance/Clinical Research (Drug Safety)

Job Function: Business Process Services

Role: Executive


Job Description:

TCS is hiring for the Medical Reviewer role!

Responsibilities:

  • Accountable for reviewing clinical, solicited, and spontaneous cases (including literature), medical assessments (labeling, causality, and company causality statement).
  • Review and assess medical sense, seriousness, and coding in the global context of drug or clinical projects.
  • Develop and maintain knowledge of disease biology and safety concerns for marketed and developmental drugs.
  • Support Drug Safety teams to ensure quality of adverse event data processing.
  • Represent the safety physician team in internal and external forums and audits.
  • Address queries related to individual case safety reports in the Patient Safety database.
  • Generate, send, and track medically relevant queries for follow-up information.
  • Provide advice on Suspected Unexpected Serious Adverse Reactions (SUSAR).
  • Ensure compliance with global and local procedural documents and TCS/client policies.

Skills Required:

  • Strong computer literacy (e.g., MS Office)
  • Good medical knowledge in drug safety
  • Understanding of drug safety and regulatory processes
  • Excellent problem-solving and decision-making skills
  • Strong communication and interpersonal skills
  • Team player with multi-disciplinary collaboration abilities

Qualifications:

  • Minimum Qualification: MBBS or Equivalent