Madrigalpharma
Sr. Director Pharmacovigilance Compliance
Madrigalpharma, Conshohocken, Pennsylvania, United States,
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.Reporting to the VP, Post-marketing Safety and Compliance, this role will focus on the development, coordination and reporting of PV quality and compliance information.Position Responsibilities:
Develop, maintain and track process for monitoring compliance of Madrigal PV System including regulatory compliance pertaining to PV requirements.Compile, analyze, and trend pharmacovigilance compliance data including root cause assessments, gap analysis and effectiveness of improvement plans.Provide monthly compliance reports to Sr. Management including associated mitigation strategies. Provide report to Qualified Person(s) for PV as required.Identify need and create PV CAPA for non-compliance. Collaborate with relevant team members to implement and track until closure.Ensure necessary procedural documents are in place to enable a compliant PV System including identification of process enhancements/continuous improvement.Collaborate with PV MD, VP, PV Safety and Compliance and other team members, as required, 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.Assume responsibility for ensuring regulatory intelligence process and management is in place. Evaluate and conduct impact assessment for legislative/regulatory changes affecting PV.Provide necessary PV quality and compliance information for inclusion in PSMF.Act as primary PV contact for inspections and audits.Collaborate with PV person(s) responsible for vendor oversight to define KPIs reflective of business practices. Implement, measure and monitor compliance.Perform QC of PV documentation to be used for external submissions such as PV aggregate reports, PSMF, RMP etc.Ensure a state of Inspection Readiness including necessary training for all relevant Madrigal employees and vendors, as required.Qualifications and Skills Required:
Bachelor's degree in healthcare/scientific related field with minimum of 8 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 pharmacovigilance compliance monitoring and quality activities.Solid experience being PV lead for inspections and audits.Expert 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 quality systems, safety systems and compliance monitoring.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 a 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.Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
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Develop, maintain and track process for monitoring compliance of Madrigal PV System including regulatory compliance pertaining to PV requirements.Compile, analyze, and trend pharmacovigilance compliance data including root cause assessments, gap analysis and effectiveness of improvement plans.Provide monthly compliance reports to Sr. Management including associated mitigation strategies. Provide report to Qualified Person(s) for PV as required.Identify need and create PV CAPA for non-compliance. Collaborate with relevant team members to implement and track until closure.Ensure necessary procedural documents are in place to enable a compliant PV System including identification of process enhancements/continuous improvement.Collaborate with PV MD, VP, PV Safety and Compliance and other team members, as required, 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.Assume responsibility for ensuring regulatory intelligence process and management is in place. Evaluate and conduct impact assessment for legislative/regulatory changes affecting PV.Provide necessary PV quality and compliance information for inclusion in PSMF.Act as primary PV contact for inspections and audits.Collaborate with PV person(s) responsible for vendor oversight to define KPIs reflective of business practices. Implement, measure and monitor compliance.Perform QC of PV documentation to be used for external submissions such as PV aggregate reports, PSMF, RMP etc.Ensure a state of Inspection Readiness including necessary training for all relevant Madrigal employees and vendors, as required.Qualifications and Skills Required:
Bachelor's degree in healthcare/scientific related field with minimum of 8 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 pharmacovigilance compliance monitoring and quality activities.Solid experience being PV lead for inspections and audits.Expert 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 quality systems, safety systems and compliance monitoring.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 a 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.Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
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