Senior PV Associate II

Role Summary

Senior PV Associate II at Madrigal, supporting postmarketing pharmacovigilance activities to maintain patient safety and regulatory compliance. Hybrid role located in Conshohocken, requiring 3 days on-site per week, reporting to the Associate Director, Postmarketing PV.

Responsibilities

• Assist with oversight of pharmacovigilance vendor activities including assessment, evaluation, tracking and reconciliation of safety information
• Perform retrospective and in-line quality checks to ensure proper coding and processing of post-marketing reports, including tracking and trending for issues and remediation effectiveness
• Create and utilize trackers to monitor vendor KPIs
• Provide review of Individual Case Safety Reports (ICSRs), including case narratives, causality assessments and coding for assigned products
• Ensure compliance with required timelines for global safety submissions and assist with other PV compliance activities
• Participate in PV safety team and safety vendor meetings
• Distribute and track meeting minutes with vendors and monthly reports
• Provide safety information when requested by management
• Ensure adherence to global regulations, SOPs, and best practices in postmarketing safety
• Assist with inspection readiness and support audits or health authority inspections as needed
• Other duties as assigned

Qualifications

• Bachelor‚Äôs degree in relevant scientific discipline. Clinical experience (e.g., RN, BSN, or PharmD) is preferred but not required
• Minimum of 3 years of relevant experience in postmarketing pharmacovigilance
• Experience with ICSR processing, narrative writing and quality review
• Working knowledge of global pharmacovigilance regulations (ICH E2A/B, FDA, EMA)
• Familiarity with safety databases (Argus, ARISg), MedDRA and WHO Drug coding
• Strong understanding of safety and pharmacovigilance principles
• Excellent attention to detail and commitment to high-quality deliverables
• Collaborative mindset with strong cross-functional communication skills
• Comfortable operating in a fast-paced, evolving biotech environment
• Proactive approach to identifying potential safety issues and recommending solutions