Manager, ICSR Compliance

About the role

Manager, ICSR Compliance — located in Horsham, PA; Raritan, NJ; or Titusville, NJ. Job Function: Quality; Sub Function: Quality Assurance; Category: People Leader.

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

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.

Qualifications

Education: A minimum of a Bachelor’s degree is required.

Experience & Skills 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.

Skills

• Compliance Management
• Corrective and Preventive Action (CAPA)
• Cross-Functional Collaboration
• Developing Others
• Fact-Based Decision Making
• Give Feedback
• Good Manufacturing Practices (GMP)
• Inclusive Leadership
• ISO 9001
• Leadership
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Validation
• Risk Assessments
• Standard Operating Procedure (SOP)
• Tactical Thinking
• Team Management

Pay

The anticipated base pay range for this position is $102,000.00 – $177,100.00.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• 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

Other

This position may require up to 5% domestic and/or international travel.