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Pharmacovigilance Physician / Senior Pharmacovigilance Physician

Full-Time

Bengaluru, India

Hyderabad, India

Job Description:

  • Perform medical review of non-serious, serious and potentially serious ICSR with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
  • Support triage of cases and determine seriousness and relatedness across products as assigned.
  • Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling, review narrative.
  • Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement activities like implementation of quality control process.
  • Provide medical guidance and expert opinion on the cases to the data entry associates and peer reviewers to help in resolving queries.
  • Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
  • Maintain PV expertise, and understanding of international safety regulations and guidelines.
  • Provide strategic and proactive safety input into development plans.
  • Support due diligence activities and pharmacovigilance agreements.
  • Responsible for completing the MR activities in safety database within the stipulated time.
  • Provide feedback to case processors on the errors/ discrepancy noted.
  • Ensure timely and appropriate regulatory submissions.

Candidate Profile:

  • MBBS / MD with 1-4 years of experience as Medical Reviewer.
  • Expert level knowledge and hands-on experience in individual case safety report medical evaluation, coding, documentation, and submission to health authorities.
  • Advanced level understanding of international Pharmacovigilance Regulations.
  • Excellent written and verbal communication skills in English.

Role Application

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