Senior Manager, Pharmacovigilance Quality Assurance (PV QA)

The Role:
Reporting to the Director, GCP Quality Assurance, the Senior Manager, Pharmacovigilance Quality Assurance (PV QA) will develop and lead risk-based quality assurance activities to support Nuvalent’s PV Organization.  The Senior Manager, PV QA will interface with the Nuvalent PV department and other internal clinical study team members, as needed, to provide PV compliance guidance.  In this role, you will establish and maintain a risk-based audit program to conduct effective audits of Nuvalent PV systems/processes, and contract service providers.  Other activities include identifying, verifying and tracking Quality Events (e.g., Deviations and CAPAs) to completion, informing management of Quality Event metrics with recommendations for resolution/corrective actions, leading or helping prepare for GCP/GVP health authority inspections, provision of regulatory compliance and QA guidance to the PV team, and providing QA input into the PV related policies/procedures.

This individual is responsible for ensuring that the appropriate quality processes and systems are in place and performed to protect the rights, safety, and welfare of our clinical patients. This individual oversees, assesses, and directly works to continuously improve GVP quality processes and to support GVP compliance at Nuvalent and ensure high quality execution of clinical trials from first in human through commercial marketing authorization. 

Responsibilities:
•    Accountable for the development, maintenance, execution, and completion of the PV Audit program
•    Responsible for initial and re-qualification of PV service providers as well as other GxP service providers involving Pharmacovigilance
•    Reviews audit reports, evaluates the impact of audit findings and tracks audit actions to closure
•    Evaluates the adequacy and completeness of Quality Events (e.g. Deviations and CAPAs) and effectiveness checks (ECs) originated from audits, inspections and/or deviations
•    Ensures that internal Nuvalent and PV service provider deviations are thoroughly investigated and appropriate CAPA and effectiveness checks are implemented to address the root causes 
•    Provides management with updates on CAPA completion status and produces metrics for safety and quality oversight committees and management review. 
•    Participates in Nuvalent internal clinical study team meetings, as well as vendor oversight and governance meetings, as needed 
•    Maintains quality agreements, quality management plans, or similar with PV service providers
•    Leads the strategy and activities for PV inspection readiness and participates in regulatory inspections, including hosting PV-related inspections 
•    Assist in the review and provide input into the quality sections of the PSMF.
•    Ensures that all PV-related training is implemented in a timely and effective manner both at Nuvalent and within external/contracted PV service providers 
•    Facilitates ongoing quality improvement measures. Works 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

Competencies Include:
•    Excellent problem solving, communication and organization skills
•    Flexibility with ambiguity, changing priorities, strong attention to detail, ability to work well under pressure and take on unfamiliar tasks
•    Ability to work in a collaborative environment, drive to learn and improve skills 
•    Ability to strategically plan, organize and manage multiple projects simultaneously 
•    Ability to prioritize tasks/issues and identify risks in the future, raising awareness to potential issues in a proactive manner. 
•    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.

Qualifications:

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