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.

Education:

• Bachelors Degree (BA/BS) Biological Science - Required
• Master Degree (MS/MA) Biological Science - Preferred

Experience:

• 3 years or more in 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

Specialized Knowledge:

• 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.

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, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. 

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [email protected]. Requests will be handled confidentially and in accordance with applicable laws. 

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key roles that the Human Resources team performs:

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.