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. Associate Director Global Pharmacovigilance Procedural Document and PSMF Management Department : Clinical Safety and Pharmacovigilance (CSPV) Reporting to the Senior Director, Global Pharmacovigilance Compliance, Standards and Training, this role will ensure compliance with global regulations with a focus on the collaboration with business process owners (BPOs) to develop and/or optimize business processes. In addition, this role will facilitate global and local Pharmacovigilance System Master File (PSMF) life-cycle management.    Position Responsibilities:  Responsible for facilitating the development of procedural documents in collaboration with business process owners and associated stakeholders across CSPV and Madrigal. Responsible for business process optimization that includes process mapping, analysis and re-engineering current and future-state business processes. Responsible for leveraging process methodologies like Value Stream Mapping, SIPOC, and swim lane diagrams to ensure regulatory compliance, identify potential gaps and process efficiencies Responsible for monitoring KPIs and identifying Key Risk Indicators (KRIs) to monitor process health, evaluate business value, and track continuous improvement efforts. Track controlled procedural document life-cycle and provide routine status reports to management. Responsible for monitoring global GVP regulatory updates, initiating and driving impact assessments to closure including proactive oversight of changes to the PV system to maintain international compliance. Responsible for PSMF life-cycle management. Direct the end-to-end over-sight, 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 PSMF 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 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. Support a state of CSPV Inspection Readiness through quality and compliance KPI monitoring and reporting. Support global PV inspections as required 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 business process management, PSMF life-cycle, and quality activities Solid knowledge of global PV regulatory requirements pertaining, 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 Direct experience with creating, tracking, compiling, and analyzing compliance and quality metrics is a must 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 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 Demonstrated ability to work independently as well as collaboratively with other team members Excellent written and verbal communication skills; must be able to communicate effectively regarding safety data, and issues related to safety and pharmacovigilance Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands.  As of the date of this posting,