Clinical Data Specialist

2 days ago


Indore, Madhya Pradesh, India beBeeMedicalReviewer Full time ₹ 1,04,000 - ₹ 1,30,878

Job Overview

  • We are seeking a skilled professional to assess and handle clinical data and case reports, particularly Suspected Unexpected Serious Adverse Reactions (SUSAR).
  • The selected candidate will ensure compliance with global and local procedural documents while maintaining up-to-date knowledge of marketed drugs under litigation.

Key Responsibilities

Clinical Data Review

  • The successful candidate will author and edit clinical and periodic report comments in the Patient Safety database.
  • They will review medical sense of cases, including seriousness, coding, and associated clinical information.
  • Providing detailed follow-up information and case updates as required is a crucial aspect of this role.

Query Management

  • Responsibilities include responding to queries from the Case Owner and detailing requests for case changes.
  • Offering product-specific advice, particularly for SUSAR cases, is also an essential part of this role.

Documentation and Compliance

  • The ideal candidate will document reviews and case comments in the Medical Review workflow (Sapphire).
  • Ensuring adherence to global and local procedural documents and policies is critical.

Desired Skills

  • An extensive medical knowledge base with the ability to critically assess clinical data is essential.
  • Attention to detail, analytical thinking, and strong communication skills are also required.

Qualifications

  • A Bachelor of Statistics, Bachelor of Technology, MBBS, MD, or MS degree is necessary.


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