REMS Manager

About the role

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.

Responsibilities

• 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.
• Single-Sponsor REMS Oversight
  • Lead operational oversight of all single-sponsor REMS programs.
  • Coordinate vendors, service providers, and internal stakeholders.
  • Monitor program performance and compliance obligations.
  • Ensure all REMS commitments are executed in accordance with FDA requirements.
  • Own REMS operational metrics and KPI reporting.
• Metrics, KPIs, and 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.
• FDA Inspections and Audits
  • 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 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.

Requirements

• Education
  • Bachelor’s Degree (BA/BS) in Biological Science – Required
  • Master’s Degree (MS/MA) in Biological Science – Preferred
• Experience
  • Minimum of 3 years of experience in REMS and pharmacovigilance, with at least 2 years in the pharmaceutical industry.
  • Strong background in REMS, PV Compliance, and Pharmacovigilance.
• Specialized Knowledge
  • In-depth knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, MHRA).
  • 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.

Pay

The base salary for this position ranges from $140,000 to $155,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.

Benefits

• Above-market, diverse, and robust health and insurance benefits.
• Significant 401(k) matching contribution to help employees save for retirement.
• Programs to promote employee well-being, supporting career enjoyment alongside life’s other commitments and opportunities.