Clinical Safety Specialist - Minneapolis

Only for registered members Minneapolis, United States

2 days ago

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Job summary

The Clinical Safety Specialist is responsible for safety and potential complaint data throughout the clinical study to ensure compliance with respect to the reporting of clinical study safety and potential complaint data to meet regulatory requirements.

The MCRS Clinical Safety Specialist will partner with various colleagues across the company (e.g., other members of the MCRS Clinical Safety team, other MCRS functions, Regulatory Affairs, Clinical teams in the Operating Units) to manage adverse event, death,
and device deficiency reporting in compliance with applicable regulatory standards and internal requirements.

Responsibilities

  • Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies
  • Review non-AE Case Report Forms to detect potential complaint and potential unreported AEs

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