ICSR Compliance Lead, PV Risk & CAPA

Johnson & Johnson Co.; Raritan (NJ); Presencial; USD 102.000 - 177.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Vacation – 120 hours

Sick time – 40 hours

Holiday pay – 13 days

Parental Leave

Descripción de la vacante

Johnson & Johnson is seeking a Manager, ICSR Compliance to lead pharmacovigilance compliance oversight for global ICSR reporting in a matrix environment. The role partners with Medical Safety, Regulatory Affairs, Clinical teams and Vendors to ensure timely investigations, CAPAs, and regulatory readiness across Horsham, PA; Raritan, NJ; and Titusville, NJ.

You will develop metrics, produce executive summaries, monitor KPIs, and drive continuous improvement while mentoring direct reports and

Formación

• Minimum 6 years in pharmaceutical industry.
• Minimum 5 years PV, drug safety, or compliance experience.
• Minimum 2 years of direct people management experience.
• Experience with ICSR case processing and regulatory reporting.
• Experience investigations, root cause analysis, and CAPA management.
• Previous people leadership in a global matrix environment.
• Strong knowledge of global pharmacovigilance regulations and reporting requirements.
• Excellent communication with senior leadership.

Responsabilidades

• Lead global ICSR reporting compliance.
• Monitor compliance metrics and KPIs.
• Identify emerging compliance risks and trends.
• Ensure SOP and regulatory alignment.
• Oversee investigations of late ICSR submissions.
• Conduct root cause analyses and CAPA management.
• Develop corrective and preventive actions with stakeholders.
• Monitor CAPA effectiveness and ensure sustainable resolution.
• Analyze compliance data and trends.
• Prepare executive compliance reports.
• Provide actionable risk-based insights.
• Develop compliance metrics and reporting processes.
• Lead and develop direct reports.
• Set goals and development plans.
• Coordinate responses to observations and inquiries.
• Maintain documentation and evidence.

Conocimientos

PV experience

Regulatory reporting

People management

Leadership

Cross-functional collab

Data analysis

Project management

GxP knowledge

Communication with leadership

Educación

Bachelor’s degree

Herramientas

PV systems

Regulatory tools

Descripción del empleo

Johnson & Johnson is seeking a Manager, ICSR Compliance to lead pharmacovigilance compliance oversight for global ICSR reporting in a matrix environment. The role partners with Medical Safety, Regulatory Affairs, Clinical teams and Vendors to ensure timely investigations, CAPAs, and regulatory readiness across Horsham, PA; Raritan, NJ; and Titusville, NJ.

You will develop metrics, produce executive summaries, monitor KPIs, and drive continuous improvement while mentoring direct reports and