Regeneron is seeking a Senior Manager, Pharmacovigilance ICSR Intake to join our Patient Safety Team!
In this role, a typical day might include:
This position is responsible for providing strategic oversight and operational leadership for global Individual Case Safety Report (ICSR) intake activities. This role ensures the timely, accurate, and compliant receipt, triage, and delivery of safety data in accordance with ICH‑GCP/GVP guidelines, global regulatory requirements, and Regeneron procedures.
This position oversees all sources of safety data—including spontaneous reports, clinical trials, literature, digital channels, medical information call centers, partner organizations, and AI‑enabled intake tools—while ensuring high standards of source data quality, data integrity, and regulatory compliance. The role partners cross‑functionally to streamline intake operations and leads modernization initiatives that leverage technology, automation, and process innovation to enhance efficiency, quality, and scalability.
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 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.
Technology, Innovation & Automation
Lead the evaluation, implementation, and optimization of AI‑enabled intake tools, automated data ingestion, natural language processing (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.
Source Data Quality & 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).
Cross‑Functional Collaboration
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.
Process Excellence & Continuous Improvement
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.
Leadership
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.
To be considered for this opportunity, you must have the following:
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.
Willingness and ability 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, 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 detail and commitment to data quality and compliance.
High level of professionalism, integrity, and customer‑service orientation.
#GDPSJobs
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)