Senior Manager, Pharmacovigilance ICSR Intake

Role Summary

Senior Manager, Pharmacovigilance ICSR Intake oversees global ICSR intake activities, providing strategic oversight and operational leadership to ensure timely, accurate, and compliant receipt, triage, and delivery of safety data in accordance with ICH-GCP/GVP guidelines and global regulatory requirements. The role oversees all sources of safety data and leads modernization initiatives that leverage technology, automation, and process innovation to enhance efficiency, data quality, and scalability. They partner cross-functionally to streamline intake operations and manage AI-enabled intake tools.

Responsibilities

• Oversee global ICSR intake operations to ensure timely case receipt, acknowledgment, triage, and handoff to downstream safety processing teams.
• Serve as the subject matter expert (SME) for ICSR intake processes, technologies, and regulatory expectations, including presentations to senior leadership and representing the team during audits and inspections.
• Manage intake-related vendors, including performance oversight, SLA/KPI management, and issue escalation.
• Lead the 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 the PV Intake Tool, workflow engines, and safety database interfaces.
• Drive modernization projects aimed at reducing manual workload and improving throughput, data quality, and compliance.
• Ensure all intake activities meet global regulatory requirements, SOPs, and inspection-ready standards.
• Monitor intake volume and quality, ensuring completeness, accuracy, and consistency of source data across channels.
• Investigate quality or compliance issues, identify root causes, and lead the development and implementation of corrective and preventive actions (CAPAs).
• Collaborate with internal partners (e.g., Medical Affairs, Clinical Operations, Commercial Quality, Digital/Social Monitoring teams) and external collaborators to support intake processes and safety data flow.
• Ensure effective and compliant ICSR transmission between intake systems, call centers, EDC systems, partner organizations, and the safety database.
• Identify operational and system improvement opportunities and lead cross-functional initiatives to optimize intake workflows.
• Contribute to or lead the creation and revision of SOPs, work instructions, training materials, and job aids.
• Provide training, mentorship, and guidance to staff on intake processes, technologies, and regulatory requirements.
• May manage and develop assigned personnel, ensuring role clarity, performance feedback, and career development.
• Model professionalism, collaboration, adaptability, and a commitment to continuous learning and operational excellence.
• Perform other related duties as assigned or requested by Manager for business needs.

Qualifications

• Bachelor’s degree required; Master’s degree preferred in life sciences, clinical research, or a healthcare discipline.
• Minimum of 10 years of 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 applications and safety database tools.
• Strong understanding of global pharmacovigilance regulations, ICSR processes, and the adverse event lifecycle.
• Advanced expertise in intake-related technology, automation, artificial intelligence (AI)/machine learning (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; able to convey complex concepts clearly.
• Strong organizational, prioritization, and project-management capabilities.
• Demonstrated ability to work collaboratively across functions and with external partners.
• Strong attention to data quality and compliance.
• High level of professionalism, integrity, and customer-service orientation.

Skills

• AI/ML applications, NLP, automation, and safety systems (e.g., Argus).
• Cross-functional collaboration, leadership, and vendor management.
• Data quality assurance, process improvement, and regulatory compliance.
• Effective communication and project management skills.

Additional Requirements

• Willingness and ability to travel domestically as required.