Senior PV Associate II

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.

Senior PV Associate II

Department: Drug Safety and Pharmacovigilance

Location: Hybrid, 3 days a week in Conshohocken office
Reports to: Associate Director, Postmarketing PV

About Madrigal:

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra™ (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

The company is in an exciting period of rapid growth and has made the decision to expand its PV capabilities to match the company’s ambitions.

Position Summary:

Reporting to the Associate Director, Postmarketing PV, the Senior PV Associate II is responsible for assisting the PV team with the tracking and quality review of ICSRs from post marketed sources and supporting the PV team in maintaining patient safety and regulatory compliance.

Key Responsibilities:

• Assist with oversight of pharmacovigilance vendor activities including but not limited to assessment, evaluation, tracking and reconciliation of safety information
• Perform retrospective and in-line quality checks (QC) to ensure proper coding and processing of post-marketing reports which includes tracking and trending for issues as well as remediation effectiveness
• Create and utilize trackers to assist team in monitoring vendor KPIs
• Provide review of Individual Case Safety Reports [ICSRs], including case narratives, causality assessments and coding for assigned products.
• Ensure compliance with the required timelines for global safety submissions and assist with other PV compliance activities, as required
• Participate in PV safety team and safety vendor meetings
• Responsible for distributing and tracking meeting minutes with vendors and monthly reports
• Assisting with providing safety information when requested by management
• Ensure adherence to global regulations, company SOPs, and best practices in postmarketing safety
• Assist with inspection readiness and support audits or health authority inspections as needed
• Other duties as assigned

Qualifications and Skills Required:

• Bachelor’s degree in relevant scientific discipline. Clinical experience (e.g. RN, BSN, or PharmD) is preferred but not required.
• Minimum of 3 years of relevant experience in postmarketing pharmacovigilance
• Experience with ICSR processing, narrative writing and quality review
• Working knowledge of global pharmacovigilance regulations (e.g., ICH E2A/B, FDA, EMA)
• Familiarity with safety databases (e.g., Argus, ARISg), MedDRA and WHO Drug coding
• Strong understanding of safety and pharmacovigilance principles
• Excellent attention to detail and commitment to high-quality deliverables
• Collaborative mindset with strong cross-functional communication skills
• Comfortable operating in a fast-paced, evolving biotech environment
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