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

Madrigal Pharmaceuticals · Conshohocken -, PA

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SafetyFull-time$167k–$204kCompany career page

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Role summary

Associate Director role managing global Pharmacovigilance System Master File (PSMF) lifecycle and optimizing business processes. Reports to Senior Director of Global Pharmacovigilance Compliance and collaborates across clinical, regulatory, and quality functions to ensure inspection readiness and regulatory compliance.

What they're looking for

Bachelor's degree in healthcare or scientific field
10+ years pharmacovigilance experience; 4+ years in PV compliance and quality
Proven track record supporting PSMF lifecycle and business process management
Knowledge of FDA, EU GVP, and pharmaceutical compliance requirements
Direct experience with case processing, data quality review, and quality metrics
Strong organizational, problem-solving, and analytical skills
Excellent written and verbal communication abilities

What you'll be doing

Manage end-to-end PSMF authoring, review, and maintenance using Veeva SafetyDocs
Coordinate with cross-functional leaders to gather accurate pharmacovigilance data inputs
Monitor global regulatory updates and drive proactive PSMF system changes for compliance
Develop and optimize business processes through mapping, analysis, and re-engineering
Compile KPIs, KRIs, and quality metrics for executive leadership and inspection readiness

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