Director, ICSR Knowledge & Process Optimization

Role Summary

The Director of ICSR Knowledge & Process Optimization is accountable for developing, maintaining, and continually 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.

Responsibilities

• 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.
• Attention to detail; able to identify and resolve discrepancies on compliance reports.
• Able to align diverse stakeholders and influence across teams, departments and geographies.
• 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.
• Excellent written and verbal communication skills; able to express complex ideas.

Qualifications

• 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 interpersonal and organizational skills required.
• Ability to work independently, prioritize effectively and work in a matrix team environment required.

Additional Requirements

• Ability and willingness to travel domestically as required.