Associate Director, Global CST, Pharmacovigilance PSMF and Business Process Management
Madrigal Pharmaceuticals
August 22, 2026
Remote friendly (Conshohocken, PA)
United States
Operations
Position Responsibilities:
- Own end-to-end Pharmacovigilance System Master File (PSMF) lifecycle management, including authoring, review, and continuous maintenance of the global PSMF and local annexes using Veeva SafetyDocs.
- Coordinate with cross-functional partners (Clinical Ops, Regulatory Affairs, Quality Assurance, QPPV Office) to gather accurate/timely data inputs.
- Maintain inspection readiness via routine narrow reviews, consistency checks, and QC evaluations.
- Monitor global GVP regulatory updates and drive PSMF system changes to ensure international compliance.
- Compile KPIs and PSMF logbooks for executive leadership and the QPPV.
- Represent the company on industry PSMF forums; identify best practices and optimize Veeva Safetydocs.
- Facilitate procedural document development with business process owners and stakeholders across CSPV.
- Optimize business processes using process mapping, re-engineering, Value Stream Mapping, SIPOC, and swim lane diagrams; track KPIs/KRIs and continuous improvement.
- Track procedural document lifecycle and provide weekly/bi-weekly status reports; support CSPV inspection readiness through KPI monitoring; review/report ICSR and aggregate report quality metrics.
Qualifications/Skills:
- BS in healthcare/scientific field; 10+ years relevant PV experience, including 4+ years in PV compliance/quality.
- Strong track record supporting PSMF lifecycle, business process management, and PV quality.
- Knowledge of FDA, EU GVP, and safety reporting/case processing with authorities (US/EU/UK).
- Experience with PSMF, quality/safety systems; case processing/management; data quality review for aggregate reports and RMPs; PV system performance evaluation.
- Experience creating/ tracking/ analyzing quality metrics; apply PV best practices.
- Highly organized, problem-solving; ability to work independently and collaboratively.
- Excellent written/verbal communication about safety/pharmacovigilance.
Benefits (as stated): Flexible paid time off; medical/dental/vision; life/disability; 401(k) (traditional/Roth/match); voluntary benefits (e.g., supplemental life, legal services); EAP mental health.
Application Instructions:
- Apply via the Madrigal Careers site (accepted on an ongoing basis).
- Own end-to-end Pharmacovigilance System Master File (PSMF) lifecycle management, including authoring, review, and continuous maintenance of the global PSMF and local annexes using Veeva SafetyDocs.
- Coordinate with cross-functional partners (Clinical Ops, Regulatory Affairs, Quality Assurance, QPPV Office) to gather accurate/timely data inputs.
- Maintain inspection readiness via routine narrow reviews, consistency checks, and QC evaluations.
- Monitor global GVP regulatory updates and drive PSMF system changes to ensure international compliance.
- Compile KPIs and PSMF logbooks for executive leadership and the QPPV.
- Represent the company on industry PSMF forums; identify best practices and optimize Veeva Safetydocs.
- Facilitate procedural document development with business process owners and stakeholders across CSPV.
- Optimize business processes using process mapping, re-engineering, Value Stream Mapping, SIPOC, and swim lane diagrams; track KPIs/KRIs and continuous improvement.
- Track procedural document lifecycle and provide weekly/bi-weekly status reports; support CSPV inspection readiness through KPI monitoring; review/report ICSR and aggregate report quality metrics.
Qualifications/Skills:
- BS in healthcare/scientific field; 10+ years relevant PV experience, including 4+ years in PV compliance/quality.
- Strong track record supporting PSMF lifecycle, business process management, and PV quality.
- Knowledge of FDA, EU GVP, and safety reporting/case processing with authorities (US/EU/UK).
- Experience with PSMF, quality/safety systems; case processing/management; data quality review for aggregate reports and RMPs; PV system performance evaluation.
- Experience creating/ tracking/ analyzing quality metrics; apply PV best practices.
- Highly organized, problem-solving; ability to work independently and collaboratively.
- Excellent written/verbal communication about safety/pharmacovigilance.
Benefits (as stated): Flexible paid time off; medical/dental/vision; life/disability; 401(k) (traditional/Roth/match); voluntary benefits (e.g., supplemental life, legal services); EAP mental health.
Application Instructions:
- Apply via the Madrigal Careers site (accepted on an ongoing basis).