Senior Director Pharmacovigilance Compliance and Risk Management

3 days ago


Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full time
Responsibilities and Requirements
  • Develop and maintain processes for monitoring compliance of Madrigal's PV System, ensuring regulatory compliance with PV requirements.
  • Compile, analyze, and trend pharmacovigilance compliance data, including root cause assessments, gap analysis, and effectiveness of improvement plans.
  • Provide monthly compliance reports to senior management, highlighting mitigation strategies and associated recommendations.
  • Identify areas of non-compliance and create PV CAPAs, collaborating with relevant team members to implement and track until closure.
  • Ensure necessary procedural documents are in place to enable a compliant PV System, identifying process enhancements and continuous improvement opportunities.
  • Collaborate with PV MD, VP, PV Safety and Compliance, and other team members to develop and implement a strategy for compliance trending and reporting on ICSR and aggregate safety reports quality and submission timelines; signal management tracking and timelines; and RMP submission and commitment timelines.
  • Assume responsibility for ensuring regulatory intelligence process and management is in place, evaluating and conducting impact assessments for legislative/regulatory changes affecting PV.
  • Provide necessary PV quality and compliance information for inclusion in PSMF.
  • Act as primary PV contact for inspections and audits.
  • Collaborate with PV person(s) responsible for vendor oversight to define KPIs reflective of business practices, implementing, measuring, and monitoring compliance.
  • Perform QC of PV documentation used for external submissions, such as PV aggregate reports, PSMF, and RMP.
  • Ensure a state of Inspection Readiness, including necessary training for all relevant Madrigal employees and vendors, as required.
Qualifications and Skills Required
  • Bachelor's degree in healthcare/scientific related field with minimum 8 years of relevant experience in PV, including at least 4 years in PV compliance and quality.
  • A proven track record in pharmacovigilance with several examples of supporting pharmacovigilance compliance monitoring and quality activities.
  • Solid experience being PV lead for inspections and audits.
  • Expert knowledge of regulatory requirements, including FDA, EU Good Pharmacovigilance Practices, and pharmaceutical industry compliance practices.
  • Solid experience in quality systems, safety systems, and compliance monitoring.
  • Direct experience and knowledge of case processing/case management, data quality review for aggregate reports, and RMPs, and evaluation/reporting of PV system performance.
  • Demonstrated ability to apply principles, concepts, and industry best practices governing pharmacovigilance in assigned projects and company deliverables.
  • Highly organized, outcome-oriented, problem-solving, understanding of research methods, and basic data analysis skills.
  • Demonstrated ability to work independently and collaboratively with other team members.
  • Excellent written and verbal communication skills, with the ability to communicate effectively regarding safety data and issues related to safety and pharmacovigilance.


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