Manager, ICSR Compliance

Johnson & Johnson

. Lead oversight of global ICSR reporting compliance against regulatory requirements and internal procedures .

Posted 10/22/2026full-timeUnited StatesMid-LevelSenior💰 $102,000 - $177,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in global ICSR reporting compliance, including regulatory requirements and internal procedures, while effectively leading teams and managing compliance metrics. Proficient in conducting investigations, root cause analyses, and CAPA management to ensure continuous improvement and compliance excellence.

Highest-signal resume keywords

Global ICSR Reporting CompliancePharmacovigilance RegulationsRoot Cause AnalysisCAPA ManagementPeople Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ICSR Case ProcessingRegulatory ReportingCompliance MonitoringData AnalysisPerformance Metrics Interpretation

Soft Skills

Analytical SkillsProblem-Solving SkillsEffective CommunicationOrganizational SkillsProject Management

Tools & Technologies

PV SystemsReporting ToolsDashboardsData Analytics Platforms

Industry Keywords

Pharmaceutical IndustryGxPQuality SystemsAudit ProcessesRegulatory Inquiries

About the role

Key responsibilities & impact

Lead oversight of global ICSR reporting compliance against regulatory requirements and internal procedures
Monitor compliance metrics, performance indicators, thresholds, and key risk indicators
Identify emerging compliance risks, trends, and recurring issues impacting reporting obligations
Ensure compliance monitoring activities follow global SOPs and regulatory requirements
Oversee investigations of late ICSR submissions and other compliance deviations
Ensure root cause analyses are completed accurately and consistently
Partner with functional areas to develop and implement corrective and preventive actions
Monitor CAPA effectiveness and verify sustainable resolution of identified issues
Analyze compliance data and performance trends
Develop compliance reports and executive summaries for leadership review
Provide actionable insights for risk-based decision-making and continuous improvement
Support development and validation of compliance metrics and reporting processes
Lead and develop direct reports
Establish individual goals and development plans and foster accountability, compliance excellence, continuous improvement, and employee engagement
Coordinate responses to compliance observations, findings, and regulatory inquiries
Maintain documentation and evidence supporting compliance oversight activities
Partner with Medical Safety, Regulatory Affairs, Clinical, and Vendors
Support regulatory inspections and internal audits

Requirements

What you’ll need

A minimum of a Bachelor's degree is required
A minimum of 6 years of pharmaceutical industry experience
A minimum of 5 years of pharmacovigilance, drug safety, or compliance experience
Minimum 2 years of direct people management experience, including performance management, coaching, development planning, and workload prioritization
Experience with ICSR case processing, regulatory reporting, or PV compliance monitoring
Experience conducting investigations, root cause analysis, and CAPA management
Previous people leadership or team lead experience
Strong knowledge of global pharmacovigilance regulations and reporting requirements
Understanding of GxP, quality systems, audit, and inspection processes
Experience interpreting compliance metrics and trends
Strong analytical and problem-solving skills
Ability to communicate effectively with senior leadership and cross-functional stakeholders
Experience working in a global matrix environment
Strong project management and organizational skills
Proficiency with PV systems, reporting tools, dashboards, and data analytics platforms

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; Colorado employees – 48 hours; Washington employees – 56 hours
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Up to 5% domestic and/or international travel may be required
Inclusive interview process and reasonable accommodation support
Equal opportunity employment