Senior PV Associate II
Madrigal Pharmaceuticals
August 22, 2026
Remote friendly (Conshohocken, PA)
United States
Operations
Key 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; track and trend issues and remediation effectiveness.
- Create and use trackers to monitor vendor KPIs.
- Review Individual Case Safety Reports (ICSRs), including case narratives, causality assessments, and coding for assigned products.
- Ensure compliance with global safety submission timelines; support other PV compliance activities as needed.
- Participate in PV safety team and safety vendor meetings.
- Distribute and track vendor meeting minutes and monthly reports.
- Provide safety information when requested by management.
- Ensure adherence to global regulations, company SOPs, and postmarketing safety best practices.
- Support inspection readiness and audits/health authority inspections as needed.
- Other duties as assigned.
Qualifications and Skills Required:
- Bachelor’s degree in a relevant scientific discipline; clinical experience (RN, BSN, or PharmD) preferred but not required.
- Minimum 3 years of postmarketing pharmacovigilance experience.
- Experience with ICSR processing, narrative writing, and quality review.
- Working knowledge of global pharmacovigilance regulations (e.g., ICH E2A/B, FDA, EMA).
- Familiarity with safety databases (e.g., Argus, ARISg), MedDRA, and WHO Drug coding.
- Strong understanding of safety/pharmacovigilance principles.
- Excellent attention to detail and commitment to high-quality deliverables.
- Collaborative mindset with strong cross-functional communication.
- Comfortable in a fast-paced, evolving biotech environment.
- Proactive approach to identifying safety issues and recommending solutions.
- 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; track and trend issues and remediation effectiveness.
- Create and use trackers to monitor vendor KPIs.
- Review Individual Case Safety Reports (ICSRs), including case narratives, causality assessments, and coding for assigned products.
- Ensure compliance with global safety submission timelines; support other PV compliance activities as needed.
- Participate in PV safety team and safety vendor meetings.
- Distribute and track vendor meeting minutes and monthly reports.
- Provide safety information when requested by management.
- Ensure adherence to global regulations, company SOPs, and postmarketing safety best practices.
- Support inspection readiness and audits/health authority inspections as needed.
- Other duties as assigned.
Qualifications and Skills Required:
- Bachelor’s degree in a relevant scientific discipline; clinical experience (RN, BSN, or PharmD) preferred but not required.
- Minimum 3 years of postmarketing pharmacovigilance experience.
- Experience with ICSR processing, narrative writing, and quality review.
- Working knowledge of global pharmacovigilance regulations (e.g., ICH E2A/B, FDA, EMA).
- Familiarity with safety databases (e.g., Argus, ARISg), MedDRA, and WHO Drug coding.
- Strong understanding of safety/pharmacovigilance principles.
- Excellent attention to detail and commitment to high-quality deliverables.
- Collaborative mindset with strong cross-functional communication.
- Comfortable in a fast-paced, evolving biotech environment.
- Proactive approach to identifying safety issues and recommending solutions.