Director, ICSR Knowledge & Process Optimization

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 robustnessfrom intake through expedited submissions and periodic reportingby 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:

• Bachelors 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.

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Does this sound like you Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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 sexual orientation gender identity or expression gender reassignment marital or civil partnership status civil status pregnancy or parental status age disability nationality citizenship status ethnic or national origin membership of the Traveler community familial status genetic information military or veteran status or any other characteristic protected under applicable law. Where required we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process unless such accommodation would impose undue hardship.

Where necessary we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment specific role level and your skills and some countries collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include depending on country and role: annual bonuses or other incentive plans equity awards pension or retirement benefits 401(k) company match health and wellness programs fitness centers insurance benefits (e.g. medical dental vision life and disability) paid time off and family support benefits. For additional information about Regeneron benefits in the U.S. please visit For other locations additional information will be provided during the recruitment process. If you have any questions please speak with your recruiter.

Please be advised that at Regeneron we believe we do our best work when we are together. For that reason many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)