Rems Manager

Description:

The REMS Manager is responsible for the operational management, compliance, and oversight of Risk Evaluation and Mitigation Strategy (REMS) programs within Global Patient Safety. Reporting to the Senior Director, Global Patient Safety and Risk Management, this role ensures that all REMS programs are implemented, maintained, and executed in compliance with FDA requirements and organizational standards.

Essential Functions:

• REMS Program Operations Manage day-to-day operations of all REMS programs across the organization. Support development and implementation of REMS programs for products in development. Ensure operational readiness for new product launches requiring REMS. Maintain oversight of all REMS operational activities and deliverables.
• Shared REMS Program Management Represent the company in shared-system REMS programs. Participate in PMO, consortium, governance, and operational meetings. Coordinate with co-sponsors and third-party administrators. Monitor and communicate changes impacting shared REMS programs.
• Lead the operational oversight and governance of single-sponsor REMS programs and organized data collection initiatives, including market research, patient support programs, registries, surveys, and similar programs; coordinate vendors and cross-functional stakeholders; ensure appropriate pharmacovigilance, regulatory, compliance, and reporting requirements are incorporated; monitor program performance and deliverables; and ensure all activities are implemented and maintained in accordance with FDA requirements, applicable regulations, approved program materials, and internal procedures.
• Own REMS operational metrics and KPI reporting. Develop dashboards and management reports. Monitor program performance and identify trends. Escalate compliance risks and operational concerns to leadership. Provide routine updates to GPS leadership regarding program status.
• Support FDA inspections and internal audits. Track commitments, findings, CAPAs, and remediation activities. Ensure all required REMS documentation is current and inspection-ready.
• Vendor and Partner Oversight Manage relationships with REMS vendors and service providers. Monitor vendor performance and contractual obligations. Participate in vendor governance activities and periodic reviews. Support quality assessments and audits of REMS vendors. Communication and Leadership Reporting Prepare executive-level updates and presentations. Communicate REMS program changes, risks, and performance metrics. Support leadership decision-making through data-driven reporting. Maintain awareness of regulatory developments impacting REMS programs. Provide REMS training to the functional teams within Amneal
• Governance and Stakeholder Management Establish and maintain REMS governance processes. Coordinate cross-functional stakeholder meetings. Track actions, decisions, risks, and escalations. Serve as the central point of contact for REMS operational matters.
• Manage relationships with REMS vendors and service providers. Monitor vendor performance and contractual obligations. Participate in vendor governance activities and periodic reviews. Support quality assessments and audits of REMS vendors. Communication and Leadership Reporting Prepare executive-level updates and presentations. Communicate REMS program changes, risks, and performance metrics. Support leadership decision-making through data-driven reporting. Maintain awareness of regulatory developments impacting REMS programs. Provide REMS training to the functional teams within Amneal
• Metrics, KPIs, and Reporting Own REMS operational metrics and KPI reporting. Develop dashboards and management reports. Monitor program performance and identify trends. Escalate compliance risks and operational concerns to leadership. Provide routine updates to GPS leadership regarding program status.

Additional Responsibilities:

• Strong understanding of FDA, EMA, MHRA, and global PV regulations.
• Expertise in pharmacovigilance quality systems and inspection readiness.
• Strong analytical and problem-solving skills.
• Excellent leadership, communication, training and stakeholder management abilities.
• Experience with safety databases and compliance metrics reporting.