Senior Manager, Pharmacovigilance Quality Assurance

Summary

Join Nuvalent, a dynamic early-stage company focused on developing cancer treatments, as their Senior Manager, Pharmacovigilance Quality Assurance. Reporting to the Director, GCP Quality Assurance, you will be responsible for developing and leading risk-based quality assurance activities to support Nuvalent’s PV Organization. This role involves establishing and maintaining an audit program, reviewing audit reports, evaluating quality events, and ensuring compliance with GVP regulations. You will also collaborate with internal teams and external service providers, participate in inspections, and contribute to quality improvement initiatives. The ideal candidate possesses extensive experience in PV QA, a strong understanding of relevant regulations, and excellent communication and problem-solving skills.

Requirements

• Have a BA/BS (or MS) or equivalent experience in a scientific discipline
• Have 8+ years’ work experience (or an equivalent combination of education and work experience) in PV QA
• Possess expertise in and ability to interpret and apply PV EU, FDA, and ICH regulations and guidelines
• Have critical thinking skills to analyze and communicate compliance related information and understand and communicate the associated risk
• Have experience auditing PV service providers, and supporting internal systems audits
• Have regulatory inspection and inspection readiness experience
• Have the ability to work independently, manage multiple priorities, and execute on goals. Have a proven ability to work in a fast-paced environment, handling multiple demands and shifting priorities with flexibility and willingness to adapt

Responsibilities

• Be accountable for the development, maintenance, execution, and completion of the PV Audit program
• Be responsible for initial and re-qualification of PV service providers as well as other GxP service providers involving Pharmacovigilance
• Review audit reports, evaluate the impact of audit findings and track audit actions to closure
• Evaluate the adequacy and completeness of Quality Events (e.g. Deviations and CAPAs) and effectiveness checks (ECs) originated from audits, inspections and/or deviations
• Ensure that internal Nuvalent and PV service provider deviations are thoroughly investigated and appropriate CAPA and effectiveness checks are implemented to address the root causes
• Provide management with updates on CAPA completion status and produce metrics for safety and quality oversight committees and management review
• Participate in Nuvalent internal clinical study team meetings, as well as vendor oversight and governance meetings, as needed
• Maintain quality agreements, quality management plans, or similar with PV service providers
• Lead the strategy and activities for PV inspection readiness and participate in regulatory inspections, including hosting PV-related inspections
• Assist in the review and provide input into the quality sections of the PSMF
• Ensure that all PV-related training is implemented in a timely and effective manner both at Nuvalent and within external/contracted PV service providers
• Facilitate ongoing quality improvement measures. Work closely with the PV functions and Quality QMS to support development of PV related policies and procedures
• Provide expertise in GVP compliance interpretation, consultation, training, and recommendations to program teams

Preferred Qualifications

• Have excellent problem solving, communication and organization skills
• Have flexibility with ambiguity, changing priorities, strong attention to detail, ability to work well under pressure and take on unfamiliar tasks
• Have the ability to work in a collaborative environment, drive to learn and improve skills
• Have the ability to strategically plan, organize and manage multiple projects simultaneously
• Have the ability to prioritize tasks/issues and identify risks in the future, raising awareness to potential issues in a proactive manner
• Have a strong work ethic, ability to meet deadlines and recognizes when the need to flex work responsibilities and deliver outside core hours helps us to deliver on our value of patient impact