Head of US Patient Safety Pharmacovigilance Case Management
Novartis
3 days ago
On-site
East Hanover, NJ
Operations
Head of US PS PV Case Management (Pharmacovigilance) — East Hanover, United States.
Role Responsibilities:
- Lead end-to-end pharmacovigilance case management operations (intake, triage, processing, follow-up, quality control, corrections, and submission) to ensure timely, accurate, compliant safety reporting.
- Serve as primary escalation point for complex, sensitive, or high-risk case processing issues and operational challenges.
- Ensure compliance with FDA regulations, ICH standards, and internal requirements.
- Oversee vendor performance and governance; manage workload forecasting/capacity models and optimize in-house vs. vendor mix.
- Drive quality, compliance, and performance using KPIs, audits, and inspection readiness.
- Champion digital, automation, and AI solutions to improve efficiency and data quality.
- Lead continuous improvement initiatives using Lean and data-driven methods to standardize and harmonize case handling.
- Build and develop high-performing teams; foster a culture of quality, compliance, accountability, continuous improvement, and inspection readiness.
- Coordinate with global countries/regions and cross-functional partners (Regulatory Affairs, Quality, Legal/Data Privacy, Risk Management, Medical Safety) to support submissions, inspections, signal detection, RMPs/REMS, labeling updates, and periodic reports.
Essential Requirements:
- Bachelor’s degree in life sciences/healthcare; advanced degree preferred (Pharm.D., M.D., Ph.D.).
- 10+ years pharmacovigilance experience with 7+ years leading case management teams/vendors in medium-to-large pharma/biotech, including regulatory submissions.
- Strong knowledge of FDA PV regulations and ICH E2A/E2D/E2B(R3); MedDRA coding and case medical evaluation.
- Hands-on experience with Argus/Veeva Vault Safety or similar, E2B(R3) exchange, EDC systems, call center telephony, and quality systems.
- Experience with drugs/biologics/medical devices/combination products.
- Project management and process excellence (e.g., Lean, Six Sigma).
- Proven leadership, negotiation, and ability to resolve complex regulatory/operational challenges.
- Experience leading inspections/audits and ensuring inspection readiness.
- Strong planning, communication, organizational skills; ability to lead enterprise transformation (digital automation/AI).
- Workflow design, resourcing, budgeting, and performance monitoring experience.
Compensation & Benefits (as stated):
- Expected salary range: $204,000–$379,000/year; performance-based cash incentive; may be eligible for annual equity awards; comprehensive benefits and time off for US-based eligible employees.
Application Instructions:
- Apply only if accessible, since Novartis is unable to offer relocation support for this role.
Role Responsibilities:
- Lead end-to-end pharmacovigilance case management operations (intake, triage, processing, follow-up, quality control, corrections, and submission) to ensure timely, accurate, compliant safety reporting.
- Serve as primary escalation point for complex, sensitive, or high-risk case processing issues and operational challenges.
- Ensure compliance with FDA regulations, ICH standards, and internal requirements.
- Oversee vendor performance and governance; manage workload forecasting/capacity models and optimize in-house vs. vendor mix.
- Drive quality, compliance, and performance using KPIs, audits, and inspection readiness.
- Champion digital, automation, and AI solutions to improve efficiency and data quality.
- Lead continuous improvement initiatives using Lean and data-driven methods to standardize and harmonize case handling.
- Build and develop high-performing teams; foster a culture of quality, compliance, accountability, continuous improvement, and inspection readiness.
- Coordinate with global countries/regions and cross-functional partners (Regulatory Affairs, Quality, Legal/Data Privacy, Risk Management, Medical Safety) to support submissions, inspections, signal detection, RMPs/REMS, labeling updates, and periodic reports.
Essential Requirements:
- Bachelor’s degree in life sciences/healthcare; advanced degree preferred (Pharm.D., M.D., Ph.D.).
- 10+ years pharmacovigilance experience with 7+ years leading case management teams/vendors in medium-to-large pharma/biotech, including regulatory submissions.
- Strong knowledge of FDA PV regulations and ICH E2A/E2D/E2B(R3); MedDRA coding and case medical evaluation.
- Hands-on experience with Argus/Veeva Vault Safety or similar, E2B(R3) exchange, EDC systems, call center telephony, and quality systems.
- Experience with drugs/biologics/medical devices/combination products.
- Project management and process excellence (e.g., Lean, Six Sigma).
- Proven leadership, negotiation, and ability to resolve complex regulatory/operational challenges.
- Experience leading inspections/audits and ensuring inspection readiness.
- Strong planning, communication, organizational skills; ability to lead enterprise transformation (digital automation/AI).
- Workflow design, resourcing, budgeting, and performance monitoring experience.
Compensation & Benefits (as stated):
- Expected salary range: $204,000–$379,000/year; performance-based cash incentive; may be eligible for annual equity awards; comprehensive benefits and time off for US-based eligible employees.
Application Instructions:
- Apply only if accessible, since Novartis is unable to offer relocation support for this role.