Summary

The Manager, ICSR Compliance is responsible for leading Pharmacovigilance (PV) compliance oversight activities related to Individual Case Safety Report (ICSR) regulatory reporting and associated compliance monitoring processes. This role ensures timely identification, investigation, and remediation of compliance risks impacting ICSR reporting obligations and drives continuous improvement through data-driven insights, trend analysis, and proactive risk management. The Manager partners with cross-functional stakeholders across Medical Safety, Regulatory Affairs, Clinical, and Vendors to monitor compliance performance, investigate deviations, implement Corrective and Preventive Actions (CAPAs), and support regulatory inspections and internal audits.

Job description

Purpose

The Manager, ICSR Compliance is responsible for leading Pharmacovigilance (PV) compliance oversight activities related to Individual Case Safety Report (ICSR) regulatory reporting and associated compliance monitoring processes. This role ensures timely identification, investigation, and remediation of compliance risks impacting ICSR reporting obligations and drives continuous improvement through data-driven insights, trend analysis, and proactive risk management. The Manager partners with cross-functional stakeholders across Medical Safety, Regulatory Affairs, Clinical, and Vendors to monitor compliance performance, investigate deviations, implement Corrective and Preventive Actions (CAPAs), and support regulatory inspections and internal audits.

Keys for success in this role include the ability to develop collaborative partnerships with stakeholders / business partners of all levels, influence without authority, resolve complex issues independently, and determine when escalation to senior management is appropriate.

Key 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 global Standard Operating Procedures (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.
Establish individual goals and development plans.
Foster a culture of accountability, compliance excellence, continuous improvement, and employee engagement.
Coordinate responses to compliance-related observations, findings, and regulatory inquiries.
Maintain documentation and evidence supporting compliance oversight activities.

Requirements

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

Pension
401(k)
Vacation
Sick time
Holiday pay
Floating holidays
Parental leave
Bereavement leave
Caregiver leave
Volunteer leave
Military spouse time-off

Company overview

Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.