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Clinical Pharmacovigilance/Drug Safety

Job Summary

Responsible for providing medical and clinical insight and guidance through clinical trials for pharmaceuticals.

Primary Responsibilities

  • Provide medical and clinical guidance to managers before, throughout, and following clinical trials.
  • Maintain consistency of safety assessments.
  • Perform a variety of safety assessments.
  • Serve in cross-functional teams as a medical and scientific representative.
  • Ensure regulatory compliance and safety throughout trial.
  • Submit periodic reports to the Food and Drug Administration.
  • Ensure that medical and causality assessments of all clinical and post-marketing adverse event fillings to foreign regulatory authorities are consistent with company policies, as well as the respective foreign regulatory requirements.
  • Address labeling concerns and updates.
  • Interpret regulatory mandates.
  • Assist with internal and external drug safety audits
  • Create company data sheets.
  • Remediate any pharmacovigilance deficiencies found during regulatory or internal audits.
  • Act as medical expert during product development.
  • Ensure subject safety during clinical studies.
  • Establish and maintain consistency of safety assessments within the US and outside the US.
  • Identify the correct actions and facilitate, support and implement them as appropriate.
  • Review performance metric data and clarify inconsistencies and trends.