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Senior Manager, Pharmacovigilance Quality Assurance
@Nuvalent, Inc.
[Hiring] Senior Manager, Pharmacovigilance Quality Assurance @Nuvalent, Inc.
Mar 14, 2025 - Nuvalent, Inc. is hiring a remote Senior Manager, Pharmacovigilance Quality Assurance. 💸 Salary: unspecified. 📍Location: USA.
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Role Description
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.
- Interface with the Nuvalent PV department and other internal clinical study team members to provide PV compliance guidance.
- Establish and maintain a risk-based audit program to conduct effective audits of Nuvalent PV systems/processes and contract service providers.
- Identify, verify, and track Quality Events (e.g., Deviations and CAPAs) to completion.
- Inform management of Quality Event metrics with recommendations for resolution/corrective actions.
- Lead or help prepare for GCP/GVP health authority inspections.
- Provide regulatory compliance and QA guidance to the PV team.
- Provide QA input into the PV related policies/procedures.
- Ensure appropriate quality processes and systems are in place to protect the rights, safety, and welfare of clinical patients.
- Oversee, assess, and continuously improve GVP quality processes to support GVP compliance at Nuvalent.
- 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.
- 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 and 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.
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.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
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All others
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Salary
💸
unspecified
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Remote
Location
USA
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Job Type
unspecified
|
Posted
Mar 14, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
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