Novartis
Pharmaceuticals
HeadofUSPatientSafetyPharmacovigilanceCaseManagement
Neural analysis suggests this role is
optimal for Lead candidates.
“Head of US Patient Safety Pharmacovigilance Case Management at Novartis. Skills: Patient Safety, Pharmacovigilance, Case Management, Operational Excellence. Lead end-to-end case management operations. Manage case intake”
What You'll Achieve.
Ensure timely, accurate, compliant safety reporting; Optimize delivery and resource mix; Enhance efficiency and data quality; Deliver quality, compliance, and innovation
Industry & Context.
Resolve complex challenges
Relocation support not offered
What They're Looking For.
Must Have
Bachelor's degree in life sciences or healthcare, 10+ years pharmacovigilance experience, 7+ years leading case management teams, 7+ years leading vendors, Experience in medium-to-large pharma/biotech, Experience with regulatory submissions, Knowledge of FDA PV regulations, Knowledge of ICH E2A/E2D/E2B(R3), Deep understanding of MedDRA coding, Deep understanding of case medical evaluation, Hands-on expertise with safety databases, Experience with E2B(R3) case exchange, Experience with Electronic Data Capture (EDC) systems, Experience with call center telephony systems, Experience with quality systems, Experience with drug, biologics, medical devices, Experience with combination products, Experience with project management, Experience with process excellence methodologies, Leadership capability, Demonstrated capability to influence, Demonstrated capability to provide strategic direction, Demonstrated capability to negotiate, Demonstrated capability to resolve complex challenges, Demonstrated experience leading inspections, Demonstrated experience leading audits, Proven people leadership experience, Excellent planning skills, Excellent communication skills, Excellent interpersonal skills, Excellent organizational skills, Ability to lead cross-functional teams, Ability to deliver complex transformation initiatives, Experience with patient support program data flows, Experience with third-party oversight, Expertise in workflow design, Expertise in resourcing, Expertise in budgeting, Expertise in performance monitoring
Nice to Have
Advanced degree (Pharm. D., M. D., Ph. D.)
What You'll Do.
Lead end-to-end case management operations
Manage case processing
Manage case follow-up
Manage quality control
Manage case corrections
Manage submission reporting
Serve as operational escalation point
Ensure compliance with FDA regulations
Ensure compliance with ICH standards
Ensure compliance with internal requirements
Oversee vendor performance
Oversee vendor governance
Oversee vendor capacity models
Optimize resource mix
Maintain workload forecasting
Maintain capacity planning
Optimize in-house vs. vendor mix
Champion digital solutions
Champion automation solutions
Champion artificial intelligence solutions
Identify continuous process improvement initiatives
Drive continuous process improvement initiatives
Simplify case handling processes
Standardize case handling processes
Harmonize case handling processes
Build high-performing teams
Foster culture of continuous improvement
Foster culture of accountability
Foster culture of quality
Foster culture of compliance
Foster culture of inspection readiness
Foster culture of learning
Serve as key partner across stakeholders
Coordinate with Global Countries
Coordinate with Regions
Collaborate with Regulatory Affairs
Collaborate with Quality
Collaborate with Legal/Data Privacy
Collaborate with Risk Management
Collaborate with Medical Safety
Support signal detection
Support labeling updates
Support periodic reports
How You'll Work.
Team & Collaboration
Cross-functional teams; Internal stakeholders; External stakeholders; Global Countries; Regions; Regulatory Affairs; Quality; Legal/Data Privacy; Risk Management; Medical Safety
Communication Scope
Communication skills
Process & Methodology
Project management, Process excellence, Lean, Six Sigma
Full Job Description
**Job Description Summary** #LI-Hybrid Location: East Hanover, United States Relocation Support: This role is based in East Hanover, United States. Novartis is unable to offer relocation support: please only apply if accessible. Ready to lead at the forefront of patient safety and pharmacovigilance? As Head of US PS PV Case Management, you will shape how critical safety information is captured, processed, and delivered ensuring patients remain at the center of everything we do. This is a high-impact leadership role where you will drive end-to-end case management excellence, champion digital and artificial intelligence-enabled transformation, and build high-performing teams that deliver quality, compliance, and innovation at scale. You’ll play a pivotal role in safeguarding patients while transforming the future of pharmacovigilance operations in a dynamic, globally connected environment. **Job Description** **Key Responsibilities:** Strategic & Operational Leadership * Lead end-to-end case management operations, including case intake, triage, processing, follow‑up, quality control, case corrections and submission ensuring timely, accurate, and compliant safety reporting. * Serve as the primary operational escalation point for complex, sensitive, or high‑risk case processing issues and case‑related risks and operational challenges. * Ensure compliance with FDA regulations, ICH standards, and internal requirements. Vendor Oversight & Quality Assurance * Oversee vendor performance, governance, and capacity models to optimize delivery and resource mix. * Maintain robust workload forecasting and capacity models; optimize in‑house vs. vendor mix, responsible for resourcing. * Drive quality, compliance, and performance through key performance indicators, audits, and inspection readiness initiatives. Digitalization, AI & Process Excellence * Champion digital, automation, and artificial intelligence solutions to enhance efficiency and data quality * Identify and drive contin
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