Medical Doctor

3 days ago

India, IN The HIRD Full time

Job Title: Medical Reviewer / Medical Quality Reviewer

Location: Pune | NCR | Kolkata

Working Model: Hybrid


Qualifications:


  • MBBS (Medical Degree), preferably with a postgraduate qualification.
  • Minimum 2+ years of experience in clinical practice or pharmacovigilance (PV).
  • Must hold valid Medical Doctor certification/licensure in the country of service.
  • Experience in the pharmaceutical industry preferred.
  • Working knowledge of international regulations and guidance documents related to worldwide reporting requirements (US/EU).


Key Responsibilities:


  • Perform comprehensive medical review of cases, ensuring consistency and accuracy of information.
  • Provide causality assessment and clinical evaluation comments as required.
  • Support the preparation of clinical trial safety assessments, regulatory submissions, and aggregate safety reports.
  • Ensure compliance with pharmacovigilance regulations and company policies.
  • Identify and resolve issues independently; escalate complex matters appropriately.
  • Demonstrate strong analytical and decision-making skills in both routine and complex scenarios.
  • Collaborate effectively within a matrix organization, working both independently and under supervision.
  • Maintain high productivity, organization, and time management to meet regulatory compliance goals.
  • Exhibit excellent oral and written communication in English.


Skills & Competencies

  • Strong understanding of pharmacovigilance processes and safety data management.
  • Proficiency in database management systems and computer applications.
  • Excellent organizational and problem-solving skills.
  • Ability to work under tight timelines while maintaining quality standards.

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