Global ICSR Compliance Leader

Johnson & Johnson Co.; Horsham (PA); On-site; USD 102,000 - 177,000; Full time

Benefits offered by this job

Vacation

Sick leave

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Job summary

Johnson & Johnson is seeking a Manager, ICSR Compliance in Horsham, PA (or nearby locations) to lead pharmacovigilance compliance for global ICSR reporting. You will drive risk-based monitoring, CAPA programs, and regulatory submissions in a matrix environment, partnering with Medical Safety, Regulatory Affairs, Clinical, and vendor teams.

The role requires 6+ years in pharma, 5+ years in PV/compliance, and 2+ years of people leadership. Travel up to 5% may be required.

Qualifications

• Minimum 6 years of pharmaceutical industry experience.
• Minimum 5 years of pharmacovigilance, drug safety, or compliance experience.
• Minimum 2 years of direct people management experience.
• Experience with ICSR case processing, regulatory reporting, or PV compliance monitoring.
• Experience conducting investigations, root cause analysis, and CAPA management.
• Strong knowledge of global pharmacovigilance regulations.

Responsibilities

• 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 are conducted in accordance with 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 to support risk-based decision-making and continuous improvement initiatives.
• Support the development and validation of compliance metrics and reporting processes.
• Lead and develop direct reports.

Skills

Compliance Management

CAPA

Cross-Functional Collaboration

Developing Others

Fact-Based Decision Making

Give Feedback

GMP

ISO 9001

Leadership

Quality Control

Quality Management Systems

Quality Standards

Quality Validation

Risk Assessments

SOP

Team Management

Education

Bachelor's degree

Tools

PV systems

Reporting tools

Dashboards

Data analytics platforms

Job description

Johnson & Johnson is seeking a Manager, ICSR Compliance in Horsham, PA (or nearby locations) to lead pharmacovigilance compliance for global ICSR reporting. You will drive risk-based monitoring, CAPA programs, and regulatory submissions in a matrix environment, partnering with Medical Safety, Regulatory Affairs, Clinical, and vendor teams.

The role requires 6+ years in pharma, 5+ years in PV/compliance, and 2+ years of people leadership. Travel up to 5% may be required.