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Drug Safety Case Manager

3 weeks ago

Hyderabad, Telangana, India beBeePharmacovigilance Full time ₹ 80,00,000 - ₹ 1,20,00,000

As a key member of our Pharmacovigilance team, you will play a crucial role in managing individual case safety reports. This includes performing initial case-level assessments to confirm the seriousness and expectedness of adverse events, composing accurate medical narratives, and generating queries for missing information.

Responsibilities:
  • Process daily adverse event cases, including coding using MedDRA, determining the seriousness and expectedness at both event and case levels.
  • Conduct case follow-up activities such as identifying necessary information to be collected during follow-up.
  • Create and review case narratives to ensure accuracy and consistency.
  • Notify clients as required for case management.
  • Support the development and delivery of training materials, contributing to the growth and knowledge of the team.
  • Highlight discrepancies or areas of concern to senior specialists and managers when related to ICSRs.
  • Maintain up-to-date knowledge of global safety regulations for medicines.
  • Peer-review cases for quality, consistency, and accuracy as needed.
Requirements:
  • Excellent verbal, written, and interpersonal communication skills.
  • High level of attention to detail and accuracy.
  • Able to identify and resolve problems efficiently.
  • Self-motivated and able to work independently within a multi-disciplinary team environment.
  • Excellent organizational and prioritization skills; able to multitask effectively.
  • Basic knowledge of pharmacovigilance principles.