Director, Pharmacovigilance Quality Assurance

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 pharmacovigivalance 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 managing 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