Patient Safety Analyst

1 day ago

Gurgaon, Haryana, India beBeePharmacovigilancer Full time ₹ 1,04,000 - ₹ 1,30,878

Job Overview

This role is part of a team responsible for processing individual case safety reports and serving as the case owner for adverse event reports, ensuring timely and accurate review, processing, quality control, and reporting.

Key Responsibilities:

  • Process adverse event reports from various sources, including thorough data entry and assessment of seriousness, expectedness, causality, and overall resolution.
  • Accurately select the suspect drug within a pharmacovigilance system.
  • Write detailed narratives summarizing all relevant medical information for individual case safety reports.
  • Code medical terms using standardized medical dictionaries (e.g., MedDRA).
  • Ensure all data is entered and coded correctly in the database, leveraging expertise in medicine.
  • Coordinate case investigations to gather necessary medical information, including query generation and follow-up with reporters in collaboration with local affiliates.
  • Perform quality checks and case clean-up as needed for aggregate report preparation.

Requirements:

  • Medical knowledge.
  • Excellent oral and written communication skills.
  • Effective team collaboration.
  • Ability to work independently under tight deadlines and shifting priorities.
  • Strong multitasking and prioritization skills in a dynamic environment.
  • Familiarity with worldwide and regional safety regulations.
  • Proficiency in pharmacovigilance systems.

Education and Experience:

  • Degree in nursing, pharmacy, science, or a related field.
  • Experience in the pharmaceutical industry (regulatory or safety) is preferred.
  • 2-3 years of experience in hospital or patient care settings is preferred.

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