Manager, Clinical Quality - Pharmacovigilance

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.