Director, Pharmacovigilance Quality Assurance

Role Summary:

The Director of Pharmacovigilance Quality Assurance (PVQA) leads the quality and compliance of pharmacovigilance activities, ensuring adherence to global regulatory standards and company policies. This role encompasses the development and implementation of quality programs, conducting audits, and maintaining readiness for inspections. This role collaborates with cross-functional teams and oversees vendor management while driving continuous improvement in pharmacovigilance processes. This role leads the design and execution of Dyne’s Pharmacovigilance Quality Management System (QMS), including policies, procedures, audits, inspections, inspection readiness, and vendor oversight, to ensure PV systems and processes meet global regulatory requirements and support high-quality regulatory submissions.  

This role is based in Waltham, MA. 

Primary Responsibilities Include 

• Lead the design, implementation, and continuous improvement of the Pharmacovigilance Quality Management System (QMS), including policies, procedures, and standards  
• Develop and execute risk-based quality plans supporting pharmacovigilance activities across clinical and commercial programs  
• Plan, conduct, and support internal and external GVP audits, inspections, and inspection readiness, including Pharmacovigilance System Master File (PSMF) contributions  
• Oversee quality systems and processes, including deviations, corrective and preventive actions (CAPAs), key performance indicators KPIs, quality indicators, and audit tracking/reporting  
• Identify, assess, and escalate quality and compliance risks, driving mitigation strategies to support regulatory submissions and patient safety  
• Ensure compliance with global GVP regulations, ICH guidelines, and company standards  
• Provide expert guidance on GVP compliance trends and requirements to internal stakeholders  
• Lead vendor qualification, oversight, and audit readiness for pharmacovigilance service providers  
• Develop and deliver PV training, SOPs, and policies in alignment with global regulatory requirements  
• Partner cross-functionally (Clinical Development, Translational Biomarkers, IT) to support clinical program compliance and sponsor oversight and safety database validation and system compliance (e.g., 21 CFR Part 11) 
• Support global regulatory submissions, interactions, and correspondence including IND-related activities 
• Advise stakeholders on GVP compliance issues and trends, ensuring inspection readiness and co-hosting regulatory audits 
• Manage the qualification of pharmacovigilance service providers, ensuring compliance with quality programs and readiness for inspections 
• Assess and escalate compliance risks from audit findings, focusing on subject safety and data integrity 

Education and Skills Requirements 

• Bachelor’s degree in a scientific discipline, advanced degree preferred 
• 10+ years in pharmacovigilance, with at least 5 years in a PV quality assurance role (or similar combination of PV and QA experience) 
• In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA), guidelines, (e.g., ICH, GVP, GxP), and safety reporting requirements 
• Broad drug experience across all clinical phases (Phase I to BLA/NDA) 
• Strong understanding of GVP Quality for pre-clinical, clinical, and commercial stages 
• Hands-on experience with pharmacovigilance systems and safety databases, including validation, audits, and compliance assessments 
• Proven experience in developing and implementing risk-based clinical quality assurance programs 
• Experience leading PVQA audits and inspections and responding to regulatory findings 
• Ability to concisely present quality events to internal stakeholders 
• Results-oriented, with a focus on setting objectives and effectively manage competing priorities and dynamic timelines 
• Flexible and creative problem-solving skills 
• Highly collaborative team player, fostering open communication and cooperation 
• Excellent communication skills, both verbal and written, with the ability to present complex information concisely to internal stakeholders. 
• Strong problem-solving skills and a results-oriented mindset, with the ability to manage competing priorities 

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