Director, ICSR Knowledge & Process Optimization
Regeneron
4 months ago
Remote friendly (Tarrytown, NY)
United States
Operations
Director, ICSR Knowledge & Process Optimization
Responsibilities:
- Develop, maintain, and continuously improve global procedures, standards, and tools for high-quality, compliant, efficient individual case safety report (ICSR) processing and adverse event reporting across developmental and marketed products.
- Ensure end-to-end ICSR process robustness (intake through expedited submissions and periodic reporting) via harmonized procedures, risk-based quality controls, and technology-enabled automation.
- Own and manage the global ICSR process framework, including standards, SOPs, work instructions, job aides, data entry conventions (DECs), templates, decision trees, and training curricula.
- Ensure procedural alignment to global pharmacovigilance regulations and guidance.
- Map and optimize end-to-end processes (intake → triage → data entry → medical review → case finalization → submissions → follow-up → reconciliation); identify waste, bottlenecks, and process failures.
- Define and review KPIs to support training compliance and effectiveness (e.g., first time right, rework/cycle time, quality event/CAPA closure timelines).
- Curate and maintain the ICSR Knowledge Base (conventions, seriousness criteria, causality heuristics, MedDRA coding conventions, follow-up rules, 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 to align vendor procedures to sponsor standards; define hand-offs, SLAs, and reconciliation controls.
- Lead readiness for internal audits and Health Authority inspections; manage remediation plans and CAPAs related to ICSR processes.
Qualifications / Requirements:
- Bachelor’s degree in life sciences or clinical research and/or a licensed healthcare professional.
- Minimum 12 years of experience in safety and safety reporting.
- Equivalent combination of relevant education and experience.
- Computer literacy; Microsoft Office (Word, Excel, PowerPoint).
- Excellent knowledge of Argus.
- Excellent verbal and written communication skills; strong interpersonal and organizational skills.
- Ability to work independently, prioritize effectively, and operate in a matrix environment.
- Ability and willingness to travel domestically as required.
Preferred / Additional Capabilities:
- People management experience; mentor and develop direct reports.
- Ability to independently identify, analyze, and resolve moderate to complex issues and trends.
- Strong knowledge of global pharmacovigilance systems/processes; translate into efficient, auditable procedures.
- Ability to plan and execute change management and measure adoption/outcomes.
- Ability to align stakeholders and influence across teams, departments, and geographies.
Benefits (as described):
- U.S. benefits may include 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.
Application instructions:
- Apply now to take your first step towards living the Regeneron Way.
Responsibilities:
- Develop, maintain, and continuously improve global procedures, standards, and tools for high-quality, compliant, efficient individual case safety report (ICSR) processing and adverse event reporting across developmental and marketed products.
- Ensure end-to-end ICSR process robustness (intake through expedited submissions and periodic reporting) via harmonized procedures, risk-based quality controls, and technology-enabled automation.
- Own and manage the global ICSR process framework, including standards, SOPs, work instructions, job aides, data entry conventions (DECs), templates, decision trees, and training curricula.
- Ensure procedural alignment to global pharmacovigilance regulations and guidance.
- Map and optimize end-to-end processes (intake → triage → data entry → medical review → case finalization → submissions → follow-up → reconciliation); identify waste, bottlenecks, and process failures.
- Define and review KPIs to support training compliance and effectiveness (e.g., first time right, rework/cycle time, quality event/CAPA closure timelines).
- Curate and maintain the ICSR Knowledge Base (conventions, seriousness criteria, causality heuristics, MedDRA coding conventions, follow-up rules, 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 to align vendor procedures to sponsor standards; define hand-offs, SLAs, and reconciliation controls.
- Lead readiness for internal audits and Health Authority inspections; manage remediation plans and CAPAs related to ICSR processes.
Qualifications / Requirements:
- Bachelor’s degree in life sciences or clinical research and/or a licensed healthcare professional.
- Minimum 12 years of experience in safety and safety reporting.
- Equivalent combination of relevant education and experience.
- Computer literacy; Microsoft Office (Word, Excel, PowerPoint).
- Excellent knowledge of Argus.
- Excellent verbal and written communication skills; strong interpersonal and organizational skills.
- Ability to work independently, prioritize effectively, and operate in a matrix environment.
- Ability and willingness to travel domestically as required.
Preferred / Additional Capabilities:
- People management experience; mentor and develop direct reports.
- Ability to independently identify, analyze, and resolve moderate to complex issues and trends.
- Strong knowledge of global pharmacovigilance systems/processes; translate into efficient, auditable procedures.
- Ability to plan and execute change management and measure adoption/outcomes.
- Ability to align stakeholders and influence across teams, departments, and geographies.
Benefits (as described):
- U.S. benefits may include 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.
Application instructions:
- Apply now to take your first step towards living the Regeneron Way.