Job Description

TheManager, Clinical Quality Assurance (Pharmacovigilance Quality) is responsible for providing strategic and operational leadership for the oversight, maintenance, and continuous improvement of Alkermes' global Pharmacovigilance Quality System.

As a key member of the Clinical Quality Assurance (CQA) organization, this individual serves as the primary Quality business partner to Drug Safety and Pharmacovigilance and provides independent quality oversight of pharmacovigilance activities, systems, processes, vendors, and business partners to ensure compliance with applicable Good Pharmacovigilance Practices (GVP), Risk Evaluation and Mitigation Strategy (REMS) requirements, global regulatory expectations, corporate quality standards, and industry best practices. The role supports both clinical development and post-marketing activities through the implementation of risk-based quality oversight, audit programs, inspection readiness initiatives, quality systems governance, and continuous improvement activities focused on patient safety, regulatory compliance, and operational excellence.

This individual partners closely with Drug Safety, Medical Affairs, Regulatory Affairs, Commercial Operations, Clinical Development, Quality, Information Technology, Legal, and external service providers to ensure the effectiveness of global pharmacovigilance and REMS compliance programs. The role is responsible for assessing quality and compliance risks, evaluating the effectiveness of pharmacovigilance and REMS controls, supporting regulatory inspection readiness, and driving sustainable remediation and continuous improvement initiatives across the organization.

This person is accountable for developing, implementing, and executing a comprehensive risk-based Pharmacovigilance Quality Program, including strategic audit planning, internal and external audits, vendor qualification and oversight, health authority inspection readiness, quality investigations, CAPA management, quality metrics, compliance monitoring, and governance activities. The role evaluates the effectiveness of the Pharmacovigilance Quality Management System and associated REMS quality processes to ensure ongoing compliance with regulatory requirements and organizational objectives.

This position provides quality oversight and assessment of key pharmacovigilance and REMS activities including:

• Adverse Event and Individual Case Safety Report (ICSR) processing
• Expedited reporting and regulatory submissions
• Signal detection, evaluation, management, and escalation
• Aggregate safety reporting (PBRERs, PSURs, DSURs)
• REMS program implementation and compliance
• REMS assessments, metrics, and effectiveness evaluations
• REMS vendors, specialty pharmacies, distributors, and third-party administrators
• Safety governance and compliance monitoring
• Pharmacovigilance agreements and Safety Data Exchange Agreements
• Safety databases and supporting computerized systems
• Vendor qualification, oversight, and performance monitoring
• Quality events, deviations, investigations, CAPAs, and change controls
• Global pharmacovigilance training and qualification programs

The individual is responsible for leading and conducting risk-based audits and assessments of pharmacovigilance systems, processes, vendors, affiliates, partners, and REMS operations, including qualification, routine surveillance, and for-cause audits. Audit activities may include evaluation of case processing and reporting compliance, signal management programs, safety governance processes, safety databases, aggregate reporting activities, REMS operational controls, REMS vendor performance, quality systems, and business partner compliance activities. The role is accountable for evaluating observations for patient safety, regulatory, quality, operational, and business impact and ensuring effective implementation and verification of corrective and preventive actions.

The Manager plays a key role in supporting global regulatory inspection readiness and compliance activities, including preparation for and participation in inspections conducted by FDA, EMA, MHRA, PMDA, Health Canada, and other health authorities. The role supports inspection management, mock inspections, health authority responses, remediation programs, and quality risk assessments affecting pharmacovigilance and REMS operations.

Responsibilities

Pharmacovigilance Quality Oversight

• Lead the development, implementation, maintenance, and continuous improvement of the global Pharmacovigilance Quality Management System.
• Provide independent Quality oversight of global pharmacovigilance processes supporting both development and commercial products.
• Assess compliance with global GVP requirements, FDA pharmacovigilance regulations, ICH guidance, and internal quality standards.
• Support governance of the Pharmacovigilance System Master File (PSMF) and associated compliance activities.
• Establish and monitor quality metrics, key performance indicators, and compliance trends.

REMS Quality Oversight

• Provide independent Quality oversight of FDA REMS programs and REMS-related vendors.
• Evaluate REMS governance structures, operational controls, monitoring processes, and effectiveness measures.
• Conduct REMS-focused audits and compliance assessments.
• Assess compliance with:
  • ETASU requirements
  • Certification programs
  • Training requirements
  • Patient enrollment processes
  • Data reporting obligations
  • Monitoring activities
• Review REMS assessments and effectiveness reports to identify compliance risks and improvement opportunities.
• Support implementation of REMS modifications and new regulatory requirements

Audit Program

• Develop and execute a global risk-based Pharmacovigilance Audit Strategy covering:
  • Pharmacovigilance systems
  • Operational processes
  • Affiliates
  • Vendors
  • License partners
  • Business partners
  • Safety databases
  • REMS operations
  • Third-party service providers
• Lead qualification, surveillance, routine, and for-cause audits.
• Evaluate audit observations for patient safety, regulatory compliance, business risk, and systemic quality impact.
• Drive implementation and verification of corrective and preventive actions resulting from audits and inspections.

Vendor and Partner Oversight

• Provide Quality oversight of:
  • Safety vendors
  • CROs
  • License partners
  • Business partners
  • Safety database providers
  • Literature monitoring vendors
  • Signal detection vendors
  • REMS vendors
  • Specialty pharmacies
  • Third-party administrators
• Evaluate vendor qualification, performance metrics, compliance trends, and requalification activities.
• Support Quality Agreements and Safety Data Exchange Agreements.

Inspection Readiness and Regulatory Compliance

• Lead global pharmacovigilance inspection readiness initiatives.
• Conduct mock inspections and gap assessments.
• Participate in health authority inspections and serve as Quality representative when required.
• Support responses, remediation programs, CAPAs, and commitments arising from inspections.
• Assess inspection findings for systemic compliance risk and effectiveness of corrective actions.

Quality Systems and Continuous Improvement

• Review and assess:
  • Deviations
  • Investigations
  • CAPAs
  • Change controls
  • Risk assessments
  • SOPs
  • Work instructions
  • Training programs
• Conduct trend analyses and effectiveness monitoring.
• Support quality risk management activities across the pharmacovigilance system.
• Drive continuous improvement initiatives and operational excellence programs.

The position provides independent Quality oversight of:

• Individual Case Safety Report (ICSR) processing
• Adverse event intake and reporting
• Expedited regulatory reporting
• Signal detection and management
• Aggregate reporting (e.g. PADER, DSUR)
• Benefit-risk evaluation processes
• Risk Management Plans (RMPs)
• REMS programs and assessments
• Safety governance committees
• Pharmacovigilance agreements
• Safety Data Exchange Agreements
• Safety databases and computerized systems
• Vendor oversight programs
• Safety training and qualification programs

Qualifications

Basic Qualifications:

• 8 years of pharmaceutical, biotechnology, CRO, or regulatory experience.
• 8 years in Pharmacovigilance Quality, REMS Experience, Drug Safety, Compliance, Auditing
• Bachelor's Degree

Preferred Qualifications:

• Direct experience leading global Pharmacovigilance Quality programs.
• Experience supporting FDA, EMA, MHRA, PMDA, and Health Canada inspections.
• Experience with REMS governance and quality oversight.
• Experience auditing:
  • Drug safety vendors
  • Specialty pharmacies
  • Call centers
  • REMS administrators
  • Patient support programs
  • Restricted distribution programs
• Expertise in:
  • EU GVP Modules
  • FDA Pharmacovigilance Regulations
  • FDA REMS Requirements
  • ICH E2 Guidance
  • Risk Management and Benefit-Risk Frameworks
  • Inspection Readiness Programs
• Experience with:
  • Argus Safety
  • ArisGlobal LifeSphere
  • Oracle Safety
  • Veeva Quality
  • TrackWise
  • ComplianceWire

The annual base salary for this position ranges from $135,000 to $149,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here

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