REMS Manager
Amneal Pharmaceuticals
August 07, 2026
Remote friendly (Bridgewater, NJ)
United States
Operations
The REMS Manager is responsible for operational management, compliance, and oversight of Risk Evaluation and Mitigation Strategy (REMS) programs within Global Patient Safety, ensuring programs are implemented, maintained, and executed in compliance with FDA requirements and organizational standards.
Essential Functions:
- Manage day-to-day operations of all REMS programs; support development/implementation for products in development; ensure readiness for new product launches; oversee REMS operational activities and deliverables.
- Represent the company in shared-system REMS programs; participate in PMO/consortium/governance/operational meetings; coordinate with co-sponsors and third-party administrators; monitor and communicate changes impacting shared REMS programs.
- Provide operational oversight and governance of single-sponsor REMS programs and data collection initiatives (e.g., market research, patient support programs, registries, surveys); coordinate vendors and stakeholders; incorporate pharmacovigilance/regulatory/compliance/reporting requirements; monitor performance and deliverables per FDA/applicable regulations, approved materials, and internal procedures.
- Own REMS operational metrics and KPI reporting; develop dashboards/management reports; monitor performance/trends; escalate compliance risks; provide routine updates to GPS leadership.
- Support FDA inspections and internal audits; track commitments, findings, CAPAs, and remediation; ensure REMS documentation is current and inspection-ready.
- Manage vendor/partner oversight; monitor performance and contractual obligations; support quality assessments/audits; prepare executive updates; communicate risks, changes, and performance metrics; provide REMS training.
- Establish/manage REMS governance processes; coordinate stakeholder meetings; track actions/decisions/risks/escalations; serve as central point of contact.
Additional Responsibilities:
- Strong understanding of FDA, EMA, MHRA, and global PV regulations.
- Expertise in pharmacovigilance quality systems and inspection readiness.
- Strong analytical/problem-solving; leadership, communication, training, and stakeholder management.
- Experience with safety databases and compliance metrics reporting.
Qualifications:
- Education: BA/BS in Biological Science (Required); MS/MA in Biological Science (Preferred).
- Experience: 3+ years in REMS and pharmacovigilance; at least 2 years in pharmaceutical industry with strong REMS/PV compliance/pharmacovigilance background.
- Specialized Knowledge: In-depth knowledge of global pharmacovigilance regulations and guidelines.
Benefits/Compensation (as stated): Base salary $140,000–$155,000/year; short-term incentive opportunity (bonus/performance-based award) within first 12 months.
Essential Functions:
- Manage day-to-day operations of all REMS programs; support development/implementation for products in development; ensure readiness for new product launches; oversee REMS operational activities and deliverables.
- Represent the company in shared-system REMS programs; participate in PMO/consortium/governance/operational meetings; coordinate with co-sponsors and third-party administrators; monitor and communicate changes impacting shared REMS programs.
- Provide operational oversight and governance of single-sponsor REMS programs and data collection initiatives (e.g., market research, patient support programs, registries, surveys); coordinate vendors and stakeholders; incorporate pharmacovigilance/regulatory/compliance/reporting requirements; monitor performance and deliverables per FDA/applicable regulations, approved materials, and internal procedures.
- Own REMS operational metrics and KPI reporting; develop dashboards/management reports; monitor performance/trends; escalate compliance risks; provide routine updates to GPS leadership.
- Support FDA inspections and internal audits; track commitments, findings, CAPAs, and remediation; ensure REMS documentation is current and inspection-ready.
- Manage vendor/partner oversight; monitor performance and contractual obligations; support quality assessments/audits; prepare executive updates; communicate risks, changes, and performance metrics; provide REMS training.
- Establish/manage REMS governance processes; coordinate stakeholder meetings; track actions/decisions/risks/escalations; serve as central point of contact.
Additional Responsibilities:
- Strong understanding of FDA, EMA, MHRA, and global PV regulations.
- Expertise in pharmacovigilance quality systems and inspection readiness.
- Strong analytical/problem-solving; leadership, communication, training, and stakeholder management.
- Experience with safety databases and compliance metrics reporting.
Qualifications:
- Education: BA/BS in Biological Science (Required); MS/MA in Biological Science (Preferred).
- Experience: 3+ years in REMS and pharmacovigilance; at least 2 years in pharmaceutical industry with strong REMS/PV compliance/pharmacovigilance background.
- Specialized Knowledge: In-depth knowledge of global pharmacovigilance regulations and guidelines.
Benefits/Compensation (as stated): Base salary $140,000–$155,000/year; short-term incentive opportunity (bonus/performance-based award) within first 12 months.