Head of Pharmacovigilance Compliance and Quality
3 days ago
About Madrigal Pharmaceuticals Corporation
Madrigal 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 reporting of safety data to regulatory authorities.
Estimated Salary: $120,000 - $180,000 per year
Job Description:Key Responsibilities:
- Compliance Monitoring: Develop and maintain processes for monitoring compliance with regulatory requirements related to pharmacovigilance, including FDA and EU Good Pharmacovigilance Practices.
- Quality Assurance: Compile, analyze, and trend pharmacovigilance quality data, including root cause assessments and effectiveness of improvement plans.
- Reporting: Provide regular compliance reports to senior management, including associated mitigation strategies and action plans.
- CAPA Management: Identify and create PV CAPAs for non-compliance, collaborate with relevant team members to implement and track until closure.
- Process Enhancement: Ensure necessary procedural documents are in place to enable a compliant PV system, including identification of process enhancements/continuous improvement.
- Collaboration: 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.
- Regulatory Intelligence: Assume responsibility for ensuring regulatory intelligence process and management is in place, evaluate and conduct impact assessment for legislative/regulatory changes affecting PV.
- PV Quality and Compliance 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 employees and vendors, as required.
- Vendor Oversight: Collaborate with PV person(s) responsible for vendor oversight to define KPIs reflective of business practices, implement, measure, and monitor compliance.
- Documentation QC: Perform QC of PV documentation to be used for external submissions such as PV aggregate reports, PSMF, RMP, etc.
Qualifications:
- 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.
- 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 offers a comprehensive benefits package, including flexible paid time off (PTO), medical, dental, vision, and life and disability insurance, as well as bonus and equity opportunities.
Madrigal is an Equal Opportunity Employer. All employment decisions are made based on qualifications, merit, and business need, 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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