Senior Director, Global Aggregate Reporting and Risk Management Plans

Role Summary

The Senior Director Global Aggregate Reporting & Risk Management Plans is a key leader responsible for providing strategic oversight and operational leadership of pharmacovigilance activities across Madrigal’s aggregate reporting and risk management plans. This role builds, maintains and monitors aggregate reporting and risk management plans to ensure patient safety, and supports global filings from a pharmacovigilance perspective. Collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Medical Writing, Biostatistics, and external PV vendors is essential to maintain a compliant and efficient safety infrastructure.

Responsibilities

• Leads review of aggregate data and author/oversee aggregate reports and Risk Management Plans (RMPs), and safety sections of global Marketing Authorization Applications
• Ensure a company core RMP is in place and maintained as new safety data becomes available to serve as the company position when filing in new global markets
• Provides scientific and regulatory guidance on adverse event assessment, benefit-risk evaluation, risk management planning
• Leads/Oversees and contributes to the preparation and review of key safety deliverables, including:
  • Development Safety Update Reports (DSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Risk Management Plans (RMPs)
  • Safety sections of INDs, NDAs, MAAs, BLAs, CTAs
  • Ensure consistent application of SOPs, regulatory compliance, and audit/inspection readiness

Qualifications

• Minimum Bachelor's degree in relevant scientific discipline required
• Advanced degree preferred: PharmD, PhD, NP/PA

Experience

• Minimum 15 years of experience in clinical safety or pharmacovigilance within the pharmaceutical or biotechnology industry
• Minimum of 5+ years of direct and indirect people management experience
• Familiarity with safety systems (e.g., Argus) and EDC platforms

Specialized Knowledge & Skills

• Plan, coordinate and execute preparation of aggregate safety reports (DSUR, PADER, PBRER, etc.)
• Experience maintaining Core and Regional Risk Management Plans (RMPs)
• Experience preparing Clinical Safety documents for global MAA submissions and Information Request responses
• Ensure governing SOPs are compliant with global regulatory requirements
• Resource planning for aggregated reports, RMPs and Information Requests
• Experience managing teams and/or vendors responsible for aggregate reports and RMPs
• Deep understanding of pharmacovigilance principles and regulatory frameworks across global markets
• Strong scientific and clinical acumen to synthesize safety data and communicate risk
• Ability to influence across matrixed environments
• Excellent organizational skills with attention to detail and operational rigor; comfortable with ambiguity
• Mentoring, developing, and scaling pharmacovigilance teams and processes
• Computer skills to support electronic systems and writing deliverables

Education

• Minimum Bachelor's degree in relevant scientific discipline
• Advanced degree preferred: PharmD, PhD, NP/PA