Medical Physician Specialist I

4 days ago

Navi Mumbai, Maharashtra, India Fortrea Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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, listedness/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, only after a tenure of 1 year.
  • Performs aggregate and signal analysis activities, as required in support of single case processing.
  • Creates, maintains, and assumes accountability for a culture of high customer service.

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:

  • 1 to 2 years of Clinical 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.

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