Senior Manager, Pharmacovigilance Quality Assurance (PV QA)

The Senior Manager, Pharmacovigilance Quality Assurance at Nuvalent is accountable for developing and executing the PV audit program, leading compliance initiatives, and ensuring that quality standards are upheld in all pharmacovigilance processes. Responsibilities include tracking quality events, conducting effective audits, managing CAPA processes, and participating in regulatory inspections, all aimed at protecting patient safety during clinical trials.

To qualify for the Senior Manager, Pharmacovigilance Quality Assurance position at Nuvalent, candidates should possess a BA/BS or an equivalent in a scientific discipline, along with at least 8 years of work experience in PV QA. Knowledge of EU, FDA, and ICH regulations is essential, coupled with auditing experience and regulatory inspection readiness expertise.

The Senior Manager, PV QA plays a crucial role in ensuring high-quality execution of clinical trials at Nuvalent by establishing and maintaining a risk-based audit program, ensuring compliance with pharmacovigilance standards, and facilitating ongoing training for team members and service providers regarding best practices and regulations to protect patient welfare!

Key competencies for a Senior Manager in Pharmacovigilance Quality Assurance at Nuvalent include excellent problem-solving skills, strong communication and organizational abilities, adaptability to changing priorities, and a collaborative attitude. The ability to manage multiple projects simultaneously while maintaining attention to detail is also critical in this role.

The Senior Manager, Pharmacovigilance Quality Assurance supports the PV team at Nuvalent by providing guidance on compliance issues, leading the auditing processes, ensuring effective CAPA resolutions, and participating actively in regulatory inspections. Their expertise is essential in shaping and improving quality strategies that impact patient safety in clinical trials.

When answering this question, highlight specific instances where you've developed compliance programs or handled audits. Discuss your knowledge of regulations and how you've applied them to ensure high-quality standards in previous roles.

Candidates should explain their meticulous approach to preparation, such as conducting mock audits, reviewing documentation, and ensuring all team members are trained and aware of their responsibilities during inspections to demonstrate readiness and compliance.

Share your methods for project management, such as using tools for prioritization, setting clear deadlines, and communicating transparently with stakeholders about timelines and potential risks to ensure successful project delivery.

When responding, provide a specific example of an initiative where you evaluated the current processes, implemented changes, and measured the outcomes. This shows your capability in driving quality improvements.

Highlight the importance of clear, transparent communication across all levels of an organization. Emphasize how communicating with both internal teams and external partners helps in maintaining compliance and ensuring quality outcomes.

In your answer, focus on the steps taken to investigate the deviation, the corrective actions implemented, and how you communicated with stakeholders. This will showcase your problem-solving and critical thinking skills.

Discuss how you develop training programs, assess staff understanding through feedback, and implement ongoing education to keep the team updated on regulations and procedures, ensuring high-quality execution.

Mention qualities such as attention to detail, analytical thinking, and the ability to remain calm under pressure, alongside strong problem-solving skills as essential for success in pharmacovigilance quality assurance.

Provide an overview of your experience with these regulations, including specific instances where you’ve applied them in practice. This emphasizes your expertise and relevance to the position.

Talk about your emphasis on open communication, setting clear expectations, and ensuring compliance with quality agreements to build strong partnerships that enhance the overall pharmacovigilance process.