Medical Director/Senior Director of Pharmacovigilance and Risk Management

2 days ago


Cambridge, Massachusetts, United States FogPharma Full time
Job Summary

FogPharma is seeking a highly experienced Medical Director/Senior Director of Pharmacovigilance and Risk Management to lead our pharmacovigilance and risk management activities. This role will be responsible for ensuring the safe and effective use of our products, and for developing and implementing strategies to mitigate potential risks.

Key Responsibilities
  • Oversee and direct all aspects of pharmacovigilance and risk management activities for all company products.
  • Lead pharmacovigilance activities, including vendor oversight and line management.
  • Design, direct, and conduct ongoing safety surveillance of company drug products.
  • Provide medical review of adverse event reports and ensure the accuracy, integrity, and completeness of information entered in the safety database.
  • Establish and conduct signal management procedures, including signal evaluation reports and recommendations for risk characterization.
Requirements
  • MD or PharmD degree or equivalent.
  • 5+ years of leadership experience in pharmaceutical safety, including a thorough understanding of case processing and other pharmacovigilance processes.
  • Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents.
  • Expertise in clinical safety assessments, safety signal detection, and risk management, including interactions with regulatory authorities.


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