Sr. Director of Compliance and Pharmacovigilance
4 days ago
Madrigal Pharmaceuticals Corporation is seeking an experienced Sr. Director of Compliance and Pharmacovigilance to lead the development, coordination, and reporting of PV quality and compliance information.
About Us:
Madrigal Pharmaceuticals Corporation is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH) and metabolic dysfunction associated steatohepatitis (MASH).
Job Description:
As a key member of our team, you will focus on ensuring the compliance of our pharmacovigilance system with regulatory requirements. Your responsibilities will include developing and maintaining processes for monitoring compliance, compiling and analyzing data, providing monthly compliance reports, and collaborating with cross-functional teams to identify and address non-compliance issues.
Responsibilities:
- Develop and Maintain Processes: Develop, maintain, and track processes for monitoring compliance of Madrigal's PV System.
- Data Analysis and Reporting: Compile, analyze, and trend pharmacovigilance compliance data, including root cause assessments, gap analysis, and effectiveness of improvement plans.
- Compliance Reports: Provide monthly compliance reports to senior management, including associated mitigation strategies, and report to Qualified Person(s) for PV as required.
- CAPA Identification and Implementation: Identify need and create PV CAPA for non-compliance, collaborate with relevant team members to implement and track until closure.
- Procedure Documentation: Ensure necessary procedural documents are in place to enable a compliant PV System, including identification of process enhancements/continuous improvement.
- Regulatory Intelligence: Collaborate with PV MD, VP, PV Safety and Compliance, and other team members to develop and implement a strategy for compliance trending and reporting on ICSR and aggregate safety reports quality and submission timelines, signal management tracking and timelines, and RMP submission and commitment timelines.
- Regulatory Changes: Assume responsibility for ensuring regulatory intelligence process and management is in place, evaluate and conduct impact assessment for legislative/regulatory changes affecting PV.
- PSMF Information: Provide necessary PV quality and compliance information for inclusion in PSMF.
- Inspection Readiness: Act as primary PV contact for inspections and audits, ensure a state of Inspection Readiness, including necessary training for all relevant Madrigal employees and vendors, as required.
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Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeAbout the RoleMadrigal Pharmaceuticals Corporation is seeking an experienced Senior Director of Pharmacovigilance Compliance to join our team. This critical role will focus on ensuring the integrity and compliance of our pharmacovigilance system, including regulatory compliance with FDA, EU Good Pharmacovigilance Practices, and industry standards.Develop and...
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Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full timeAbout Madrigal Pharmaceuticals CorporationMadrigal Pharmaceuticals Corporation is a biopharmaceutical company focused on developing innovative therapies for non-alcoholic steatohepatitis (NASH) and other metabolic disorders.This role will be responsible for ensuring the quality and compliance of our pharmacovigilance systems, including monitoring and...
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