REMS Manager

Amneal

About The Position

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.

Requirements

Bachelors Degree (BA/BS) Biological Science - Required
Minimum of 3 years of experience in REMS and pharmacovigilance, with at least 2 years in Pharmaceutical Industry with strong REMS, PV Compliance and Pharmacovigilance background
In-depth knowledge of global pharmacovigilance regulations and guidelines.
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.

Nice To Haves

Master Degree (MS/MA) Biological Science - Preferred

Responsibilities

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.
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 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.
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.
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.
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.
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.