Senior Director of Pharmacovigilance Compliance

1 week ago


Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full time
About the Role

Madrigal Pharmaceuticals Corporation is seeking an experienced Senior Director of Pharmacovigilance Compliance to join our team. This critical role will focus on ensuring the integrity and compliance of our pharmacovigilance system, including regulatory compliance with FDA, EU Good Pharmacovigilance Practices, and industry standards.

  • Develop and maintain processes for monitoring compliance with pharmacovigilance requirements
  • Compile, analyze, and trend pharmacovigilance compliance data, including root cause assessments and effectiveness of improvement plans
  • Provide monthly compliance reports to senior management and Qualified Person(s) for PV
  • Identify areas for improvement and develop CAPAs for non-compliance
  • Ensure necessary procedural documents are in place for a compliant pharmacovigilance system
Responsibilities
  • Collaborate with cross-functional teams to develop and implement a comprehensive pharmacovigilance strategy
  • Provide regulatory intelligence and management support to ensure compliance with changing regulations
  • Develop and maintain quality metrics for pharmacovigilance
  • Act as primary PV contact for inspections and audits
  • Ensure a state of inspection readiness for our organization
Qualifications and Skills
  • Bachelor's degree in healthcare or scientific field with minimum 8 years of relevant experience in PV, including 4 years in PV compliance and quality
  • Proven track record in pharmacovigilance with experience in compliance monitoring and quality activities
  • Expert knowledge of regulatory requirements, including FDA, EU Good Pharmacovigilance Practices, and industry standards
  • Solid experience in quality systems, safety systems, and compliance monitoring


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