Instagram
youtube
Facebook
1-7 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

Job Function: Business Process Services

Role: Executive

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


Job Description:

TCS is hiring for a Medical Reviewer role!

Responsibilities:

  • Perform medical review of clinical, solicited, and spontaneous cases (including literature articles), providing medical assessments, causality evaluations, and labeling.
  • Review the medical aspects of cases, including seriousness, AE/SAE terms, suspect drugs, concomitant medications, lab data, and medical history.
  • Develop and maintain knowledge of disease biology and safety concerns for marketed drugs and drugs in development.
  • Support the Drug Safety teams with medical concepts to ensure quality in adverse event data processing.
  • Represent the safety physician team in internal and client safety forums and audits.
  • Address queries and comments related to individual case safety reports (ICSRs) in the Patient Safety database.
  • Generate and track medically relevant queries for follow-up information on case reports.
  • Provide product advice for Suspected Unexpected Serious Adverse Reactions (SUSARs).
  • Ensure compliance with global and local procedural documents, and implement policies, procedures, and processes.

Skills Required:

  • Proficiency in MS Office and computer literacy.
  • Aptitude for self-directed learning and good medical knowledge in drug safety.
  • Strong understanding of Drug Safety and Regulatory processes.
  • Excellent problem-solving, decision-making, and communication skills.
  • Ability to function effectively as a team player in a multi-disciplinary environment.
  • Ability to prioritize, plan, and take initiative.

Qualifications:

  • Minimum Qualification: MBBS or equivalent.

Role Category: Business Process Services