Description

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:

Ability to further develop and maintain processes for high quality and compliant
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),
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.
Ensure procedural alignment to global regulations and guidance.
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.
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.)
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).
Standardize and deploy role-based training and certification for internal teams and vendors; measure learning effectiveness and error reduction.
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).
Oversee readiness for internal audits and Health Authority inspections; lead remediation plans and CAPAs related to ICSR processes.
Performs other related duties as assigned or requested per business needs.
Able to independently identify, analyze, and resolve moderate to complex issues and trends.
Strong knowledge of global pharmacovigilance regulations, systems, and processes and ability to translate those into efficient and auditable procedures.
Previous people management experience with the ability to mentor and develop direct reports.
Excellent written and verbal communication skills. Able to express complex ideas.
Able to align diverse stakeholders and influence across teams, departments and geographies.
Able to identify and document regulatory non-compliance and any related issues.
Plans and executes change management; measures adoption and outcomes.
Uses metrics to prioritize and verify improvements; comfortable with data and dashboards.
Excellent organizational and interpersonal skills.
Attention to detail; able to identify and resolve discrepancies on compliance reports.

To be considered for this opportunity, you must have the following:

Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required.
Minimum of 12 years of experience in safety and safety reporting.
Equivalent combination of relevant education and experience.
Computer literacy and experience working with Microsoft Office (Word, Excel, PowerPoint) required
Excellent knowledge of Argus and its applications.
Excellent verbal and written communication skills required.
Excellent interpersonal and organizational skills required.
Ability to work independently, prioritize effectively and work in a matrix team environment required.
Ability and willingness to travel domestically as required.

#GDRAJobs

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)

$183,100.00 - $305,200.00

Director, ICSR Knowledge & Process Optimization

Description

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