Director, Pharmacovigilance Quality

How You Will Achieve More:

Are you a strategic quality leader passionate about patient safety and regulatory excellence? We're seeking an exceptional Director of Pharmacovigilance Quality Assurance to build and lead our global PV quality function during an exciting period of growth.

As a key member of our R&D quality leadership team, you'll partner with Pharmacovigilance to embed quality and compliance across all product safety activities—from clinical development through post-marketing surveillance. This isn't just oversight; it's strategic partnership that protects patients, satisfies regulators, and enables business success.

You'll establish our risk-based QA oversight program, serve as our company's voice during regulatory inspections, and mentor a team dedicated to world-class pharmacovigilance practices. If you thrive at the intersection of strategic thinking and hands-on quality leadership, this role offers the perfect platform to make a measurable impact on patient well-being.

Responsibilities:

Strategic Leadership & Quality Oversight

• Build and lead a world-class PV quality function that protects patients and satisfies regulators. Ensuring adherence to reporting standards and company policies
• Develop and implement a global PV QA strategy and risk-based audit program to ensure compliance with FDA, EMA, MHRA, ICH, and other international regulatory requirements
• Establish and maintain a compliant QA oversight program for PV,
• Serve as the primary Quality Assurance Subject Matter Expert (SME) for Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) as related to safety data

Audit & Inspection Management

• Drive a risk-based approach to creating, maintaining, and executing the annual PV audit program focusing on:
• Incoming safety data from all sources
• Compliant case processing and reporting
• Medical review and signal detection
• Risk management programs and safety-related labeling
• Schedule, personally conduct, and/or manage quality audits for PV operations, vendors, partners, and commercial safety activities
• Lead inspection readiness activities and serve as the company representative during regulatory agency inspections and mock audits
• Oversee and manage internal and external audits of PV vendors, electronic safety systems, and clinical/post-marketing PV documents

Quality Systems Management

• Provide comprehensive QA oversight for end-to-end PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment
• Oversee the Quality Management System (QMS) with appropriate metrics, trending analysis, and risk indicators
• Manage the PV deviation and CAPA program, including investigation and timely closure of issues
• Author and maintain QA PV Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Provide quality oversight for all PV-related documents, ensuring alignment with regulatory requirements

Cross-Functional Collaboration

• Partner with the PV Operational team to problem-solve, strategize, and provide compliance guidance
• Collaborate with Clinical Development, Regulatory Affairs, Commercial Operations, and other departments to optimize GVP education, training, compliance, and inspection readiness
• Act as Key Opinion Leader for GVP regulations, process strategies, and regulatory guidance (domestic and international)
• Assist in vendor selection, qualification, oversight, and risk-based auditing of third parties supporting PV activities
• Continuous Improvement & Regulatory Intelligence
• Lead process improvement projects and identify gaps in systems and processes as part of continuous improvement initiatives
• Stay current with new and revised regulations, industry trends, and health authority expectations
• Develop and present periodic metrics and risk management reports to company leadership
• Provide global GVP training when requested

About You:

Education

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or Allied Health/Science AND 10-15 years of pharmaceutical industry experience (minimum 7-10 years supporting pharmacovigilance) or Master's degree in a related discipline AND 7+ years of related experience or PhD in a related discipline AND 4+ years of related experience

Required Experience & Expertise

• Demonstrated ability to provide QA oversight of PV activities and ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, GCP, and SOPs
• Expert knowledge of current ICH and health authority requirements (FDA, EMA, MHRA, ROW), expectations, and trends in patient safety and pharmacovigilance
• Proven experience effectively managing regulatory agency inspections and serving as company representative
• Deep understanding of global GVP regulations (US/MHRA/EU/ROW), Part 11 computer systems, and all types of PV internal and external auditing
• Strong knowledge of pharmacovigilance processes, risk-based quality systems, and clinical development
• Comprehensive understanding of clinical research aspects including protocol development, CRF design, trial management, monitoring, vendor management/oversight, data management, statistical analysis, and regulatory submissions
• Strategic thinking with ability to contribute to company objectives and achieve goals in creative and effective ways
• Excellent communication skills (verbal, written, and presentation) with ability to interact effectively with people at all levels of the organization and with external collaborators, vendors, and health authority representatives
• Ability to work in a remote/hybrid environment with strong interpersonal communication skills
• Hands-on leadership style with ability to deal with ambiguity and provide creative and pragmatic solutions to issues and risks

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Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please click here.