Regeneron is seeking a Director, ICSR Knowledge & Process Optimization to join our organization.
In this role, a typical day might include:
The Director of ICSR Knowledge & Process Optimization is accountable for developing, maintaining, and continuously improving global procedures, standards, and tools that enable high-quality, compliant, and efficient individual case safety report (ICSR) processing and adverse event reporting across both developmental and marketed products. This role ensures end-to-end ICSR process robustness—from intake through expedited submissions and periodic reporting—by driving harmonized procedures, risk-based quality controls, and technology-enabled automation. The Director partners closely with GPS Standards and Training, Signal Management, Safety Sciences, Clinical Development, Quality/QA, Regulatory, Medical Information, IT, and Commercial to ensure timely compliance with global regulations while advancing operational excellence.
This role might be for you if you can/have:
1. Ability to further develop and maintain processes for high quality and compliant
2. ICSR case processing from all sources for reporting to all applicable destinations. This includes owning the global ICSR process framework: standards, SOPs, Work Instructions (WIs),
3. Job aides, data entry conventions (DECs), templates, decision trees, and training curricula for all case types for the various resources performing case evaluation, medical assessment, and submissions.
4. Ensure procedural alignment to global regulations and guidance.
5. Map end-to-end processes (intake → triage → data entry → medical review → case finalization → submissions → follow-up → reconciliation); identify waste, bottlenecks, and process failures. This includes partnering with IT/Safety Systems to evaluate, pilot, and scale technologies and automation.
6. Define and review key performance indicators to ensure training compliance and effectiveness (e.g. first time right (FTR); rework/cycle time; quality event/CAPA closure timelines, etc.)
7. Curate and maintain the ICSR Knowledge Base (product/study-specific conventions, seriousness criteria, causality heuristics, MedDRA coding conventions, follow-up rules, local regulatory nuances, partner agreements).
8. Standardize and deploy role-based training and certification for internal teams and vendors; measure learning effectiveness and error reduction.
9. Partner with Vendor Relationship Management/QA/other stakeholders to ensure vendor procedures align to sponsor standards; define hand-offs, SLAs, and reconciliation controls (e.g., MI/Call Center, literature vendors, third party vendors).
10. Oversee readiness for internal audits and Health Authority inspections; lead remediation plans and CAPAs related to ICSR processes.
11. Performs other related duties as assigned or requested per business needs.
12. Able to independently identify, analyze, and resolve moderate to complex issues and trends.
13. Strong knowledge of global pharmacovigilance regulations, systems, and processes and ability to translate those into efficient and auditable procedures.
14. Previous people management experience with the ability to mentor and develop direct reports.
15. Excellent written and verbal communication skills. Able to express complex ideas.
16. Able to align diverse stakeholders and influence across teams, departments and geographies.
17. Able to identify and document regulatory non-compliance and any related issues.
18. Plans and executes change management; measures adoption and outcomes.
19. Uses metrics to prioritize and verify improvements; comfortable with data and dashboards.
20. Excellent organizational and interpersonal skills.
21. Attention to detail; able to identify and resolve discrepancies on compliance reports.
To be considered for this opportunity, you must have the following:
22. Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required.
23. Minimum of 12 years of experience in safety and safety reporting.
24. Equivalent combination of relevant education and experience.
25. Computer literacy and experience working with Microsoft Office (Word, Excel, PowerPoint) required
26. Excellent knowledge of Argus and its applications.
27. Excellent verbal and written communication skills required.
28. Excellent interpersonal and organizational skills required.
29. Ability to work independently, prioritize effectively and work in a matrix team environment required.
30. Ability and willingness to travel domestically as required.
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