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Medical Safety Monitor

Job description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

"The candidate must have 3+ years of clinical and industry experience of more than 3 years including experience on medical devices ; Should have worked as medical safety reviewer/safety physician, able to prepare aggregate reports, performed signal detection activities, MedDRA coding, clinical study reports and have good communication skills to participate in client meetings."

Main Responsibilities

  • • Assists with all activities related to establishing and managing all safety-related processes.
  • • Reviews all safety related data for various clinical trials.
  • • Reviews clinical safety databases.
  • • Write Safety narrative reports for all notable clinical events.
  • • Support/Author regulatory notifications and filings.
  • • Support/Author periodic safety reports to the FDA and IRB/IECs.
  • • Support preparation of safety section of clinical study reports, Clinical Expert
  • reviews, clinical section of device reports, and other ad hoc reports documents as needed to support formal (PMA) regulatory filings.
  • • Assist in formulating and implementing guidelines and processes in establishing independent safety monitoring boards and committees for clinical trials.
  • • Perform MedDRA coding or SOC coding.
  • • Work with applicable departments in regard to the activities of the clinical trial(s).

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Medical Safety Monitor

Bengaluru, Karnataka
Full Time

Published on 09/16/2020