Associate Director, Global CST, Pharmacovigilance PSMF and Business Process Management

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

Reporting to the Senior Director, Global Pharmacovigilance Compliance, Standards and Training, this role will focus on the collaboration with business process owners (BPOs) develop and/or optimize business processes. In addition, this role will provide Pharmacovigilance System Master File (PSMF) life-cycle management. 

Position Responsibilities: 

• Responsible for PSMF life-cycle management. Direct the end-to-end authoring, review, and continuous maintenance of the global PSMF and relevant local PSMF annexes leveraging Veeva SafetyDocs
• Responsible for the seamless coordination with cross-functional leaders (e.g., Clinical Operations, Regulatory Affairs, Quality Assurance, and the QPPV Office) to gather accurate, timely data inputs.
• Responsible for ensuring the PSMF is perpetually ready for health authority inspections by conducting routine narrow reviews, consistency checks, and quality control (QC) evaluations.
• Responsible for monitoring global GVP regulatory updates and proactively drive changes to the PSMF system to maintain international compliance
• Responsible for compiling Key Performance Indicators (KPIs) and PSMF logbooks for presentation to executive leadership and the Qualified Person Responsible for Pharmacovigilance (QPPV)
• Responsible for representing Madrigal on industry PSMF forums to identify best practices and optimize Veeva Safetydocs technology.
• Responsible for facilitating the development of procedural documents in collaboration with business process owners and associated stakeholders across CSPV.
• Responsible for business process optimization that includes process mapping, analysis and re-engineering current and future-state business processes.
• Responsible for leverage process methodologies like Value Stream Mapping, SIPOC, and swim lane diagrams.
• Responsible for monitoring KPIs and identify Key Risk Indicators (KRIs) to monitor process health, evaluate business value, and track continuous improvement efforts
• Track controlled procedural document life-cycle and provide weekly/bi-weekly status reports to management.
• Conduct
• Support a state of CSPV Inspection Readiness through quality and compliance KPI monitoring and reporting
• Review and report on ICSR and Aggregate report quality metrics taking a continuous improvement approach
   

Qualifications and Skills

• Bachelor's degree in healthcare/scientific related field with minimum of 10+ years of relevant experience in PV with a minimum of 4 years in PV compliance and quality
• A proven track record in pharmacovigilance with several examples of supporting PSMF life-cycle, business process management, and quality activities
• Knowledge of regulatory requirements pertaining to FDA, EU Good Pharmacovigilance Practices , and pharmaceutical industry compliance practices, which includes solid knowledge of safety reporting in clinical trials, post marketing surveillance, case processing and reporting to global Regulatory Authorities, in particular US, EU and UK.
• Solid experience in PSMF, quality systems, and safety systems
• Direct experience and knowledge of case processing/ case management, data quality review for aggregate reports and RMPs and evaluation/reporting of PV system performance is required
• Direct experience with creating, tracking, compiling, and analyzing quality metrics is must
• Demonstrated ability to apply principles, concepts and industry best