Senior Manager, Pharmacovigilance ICSR Intake - AI Enablement
Regeneron
2 months ago
Remote friendly (Tarrytown, NY)
United States
Operations
In This Role, a Typical Day Might Include
- Provide strategic oversight and operational leadership for global Individual Case Safety Report (ICSR) intake activities, ensuring timely, accurate, and compliant receipt, triage, and delivery of safety data in line with ICH-GCP/GVP, global regulations, and company procedures.
- Oversee all sources of safety data (spontaneous reports, clinical trials, literature, digital channels, medical information call centers, partner organizations, and AI-enabled intake tools) while ensuring source data quality, integrity, and regulatory compliance.
- Partner cross-functionally to streamline intake operations and lead modernization initiatives using technology, automation, and process innovation.
This Role Might Be For You If You Can/have
Operational Leadership
- Oversee global ICSR intake operations to ensure timely case receipt, acknowledgment, triage, and handoff to downstream safety processing teams.
- Serve as subject matter expert (SME) for ICSR intake processes/technologies/regulatory expectations; present to senior leadership; represent the team during audits and inspections.
- Manage intake-related vendors, including performance oversight, SLA/KPI management, and issue escalation.
Technology, Innovation & Automation
- Lead evaluation, implementation, and optimization of AI-enabled intake tools, automated data ingestion, NLP capabilities, workflow automation, and system upgrades.
- Partner with Safety Systems and IT to enhance PV Intake Tool, workflow engines, and safety database interfaces.
- Drive modernization projects to reduce manual workload and improve throughput, data quality, and compliance.
Source Data Quality & Compliance
- Ensure intake activities meet global regulatory requirements, SOPs, and inspection-ready standards.
- Monitor intake volume/quality for completeness, accuracy, and consistency across channels.
- Investigate quality/compliance issues, determine root causes, and lead CAPAs.
Cross-Functional Collaboration
- Collaborate with Medical Affairs, Clinical Operations, Commercial Quality, Digital/Social Monitoring teams, and external collaborators to support intake and safety data flow.
- Ensure effective and compliant ICSR transmission between intake systems, call centers, EDC systems, partner organizations, and the safety database.
Process Excellence & Continuous Improvement
- Identify improvement opportunities and lead initiatives to optimize intake workflows.
- Contribute to or lead creation/revision of SOPs, work instructions, training materials, and job aids.
- Provide training, mentorship, and guidance on intake processes, technologies, and regulatory requirements.
Leadership
- May manage and develop assigned personnel (role clarity, performance feedback, career development).
- Model professionalism, collaboration, adaptability, and commitment to continuous learning and operational excellence.
- Perform other related duties as assigned/requested by the Manager.
Qualifications
- Bachelor’s degree required; Master’s preferred in life sciences, clinical research, or a healthcare discipline.
- 10+ years relevant industry experience with a Bachelor’s degree, or 7+ years with a Master’s degree, in pharmacovigilance, safety operations, or safety reporting.
- Experience with ICSR intake systems, automated workflows, digital channels, and vendor oversight.
- Proficiency with Microsoft Office and safety database tools.
- Ability and willingness to travel domestically as required.
- Strong understanding of global pharmacovigilance regulations, ICSR processes, and the adverse event lifecycle.
- Advanced expertise in intake-related technology, automation, AI/ML applications, and safety systems (e.g., Argus).
- Ability to independently identify, analyze, and solve complex operational and data-related issues.
- Excellent written and verbal communication skills.
- Strong organizational, prioritization, and project-management skills.
- Demonstrated ability to collaborate across functions and with external partners.
- Strong attention to detail; commitment to data quality and compliance.
- High professionalism, integrity, and customer-service orientation.
Application Instructions
- Apply now to take your first step towards living the Regeneron Way.
- Provide strategic oversight and operational leadership for global Individual Case Safety Report (ICSR) intake activities, ensuring timely, accurate, and compliant receipt, triage, and delivery of safety data in line with ICH-GCP/GVP, global regulations, and company procedures.
- Oversee all sources of safety data (spontaneous reports, clinical trials, literature, digital channels, medical information call centers, partner organizations, and AI-enabled intake tools) while ensuring source data quality, integrity, and regulatory compliance.
- Partner cross-functionally to streamline intake operations and lead modernization initiatives using technology, automation, and process innovation.
This Role Might Be For You If You Can/have
Operational Leadership
- Oversee global ICSR intake operations to ensure timely case receipt, acknowledgment, triage, and handoff to downstream safety processing teams.
- Serve as subject matter expert (SME) for ICSR intake processes/technologies/regulatory expectations; present to senior leadership; represent the team during audits and inspections.
- Manage intake-related vendors, including performance oversight, SLA/KPI management, and issue escalation.
Technology, Innovation & Automation
- Lead evaluation, implementation, and optimization of AI-enabled intake tools, automated data ingestion, NLP capabilities, workflow automation, and system upgrades.
- Partner with Safety Systems and IT to enhance PV Intake Tool, workflow engines, and safety database interfaces.
- Drive modernization projects to reduce manual workload and improve throughput, data quality, and compliance.
Source Data Quality & Compliance
- Ensure intake activities meet global regulatory requirements, SOPs, and inspection-ready standards.
- Monitor intake volume/quality for completeness, accuracy, and consistency across channels.
- Investigate quality/compliance issues, determine root causes, and lead CAPAs.
Cross-Functional Collaboration
- Collaborate with Medical Affairs, Clinical Operations, Commercial Quality, Digital/Social Monitoring teams, and external collaborators to support intake and safety data flow.
- Ensure effective and compliant ICSR transmission between intake systems, call centers, EDC systems, partner organizations, and the safety database.
Process Excellence & Continuous Improvement
- Identify improvement opportunities and lead initiatives to optimize intake workflows.
- Contribute to or lead creation/revision of SOPs, work instructions, training materials, and job aids.
- Provide training, mentorship, and guidance on intake processes, technologies, and regulatory requirements.
Leadership
- May manage and develop assigned personnel (role clarity, performance feedback, career development).
- Model professionalism, collaboration, adaptability, and commitment to continuous learning and operational excellence.
- Perform other related duties as assigned/requested by the Manager.
Qualifications
- Bachelor’s degree required; Master’s preferred in life sciences, clinical research, or a healthcare discipline.
- 10+ years relevant industry experience with a Bachelor’s degree, or 7+ years with a Master’s degree, in pharmacovigilance, safety operations, or safety reporting.
- Experience with ICSR intake systems, automated workflows, digital channels, and vendor oversight.
- Proficiency with Microsoft Office and safety database tools.
- Ability and willingness to travel domestically as required.
- Strong understanding of global pharmacovigilance regulations, ICSR processes, and the adverse event lifecycle.
- Advanced expertise in intake-related technology, automation, AI/ML applications, and safety systems (e.g., Argus).
- Ability to independently identify, analyze, and solve complex operational and data-related issues.
- Excellent written and verbal communication skills.
- Strong organizational, prioritization, and project-management skills.
- Demonstrated ability to collaborate across functions and with external partners.
- Strong attention to detail; commitment to data quality and compliance.
- High professionalism, integrity, and customer-service orientation.
Application Instructions
- Apply now to take your first step towards living the Regeneron Way.