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Associate Medical Manager

Associate Medical Manager

ConfidentialPune, India
4 days ago
Job description

Job Overview

Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period.

Summary Of Responsibilities

  • Undertake primary medical review of cases, including medical assessment of the case for seriousness, listed / labeling, causality, adverse event coding and narrative review.
  • Update and document daily case data, case-feedback in appropriate trackers / tools to facilitate tracking and workflow management.
  • Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs.
  • Provide training and guidance to the case processing team on medical aspects of case processing.
  • Performs secondary medical review (QC role) and retrospective review of cases reviewed (QA role), as required for measuring quality of deliverables, identifying error trends, training needs and areas of improvement.
  • Performs aggregate medical review and signal detection / analysis activities, as required.
  • Enhances existing client relationships whenever possible.
  • Creates, maintains, and assumes accountability for a culture of high customer service.
  • Participates in process improvement activities across Company.
  • And all other duties as needed or assigned.

Qualifications (Minimum Required)

  • Bachelor's degree in medical science or MD or DO or equivalent degree.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Language Skills :
  • Speaking : English at ILR level 3+ or higher.
  • Writing / Reading : English at ILR level 4+ or higher.
  • Experience (Minimum Required)

  • Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures.
  • Knowledge and understanding of regulatory requirements for Clinical Research.
  • Knowledge and understanding of ICH-GCP guidelines.
  • Preferred Qualifications Include

  • Good understanding of regulatory requirements relating to Pharmacovigilance.
  • Up to 2 years pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and / or clinical research.
  • 1 to 2 years of clinicial practice experience.
  • Physical Demands / Work Environment

  • Office or home-based environment, as requested by the line manager.
  • Learn more about our EEO & Accommodations request here.

    Skills Required

    Case Processing, Pharmacovigilance

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