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

About the role

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.

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

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 leveraging process methodologies like Value Stream Mapping, SIPOC, and swim lane diagrams.
• 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 weekly/bi-weekly status reports to management.
• Conduct support for 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 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

Pay

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, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $166,500 - $203,500 per year.

Benefits

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for 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. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.