Associate Director, Pharmacovigilance Quality Assurance

As the Associate Director, Pharmacovigilance Quality Assurance at Sarepta, you'll be in charge of overseeing the GVP quality oversight, managing the audit program, and providing regulatory guidance. Your role involves collaborating with internal teams, developing audit strategies, and ensuring compliance across various operations, making your contribution essential to the company's mission.

To qualify for the Associate Director, Pharmacovigilance Quality Assurance position at Sarepta, candidates typically need a strong background in pharmacovigilance, quality assurance, and regulatory compliance. A relevant degree and significant experience in clinical development and quality systems are crucial for success in this role.

In the Associate Director, Pharmacovigilance Quality Assurance role at Sarepta, your focus on overseeing quality and compliance is directly tied to patient safety. By managing audits and ensuring adherence to regulatory standards, you help safeguard patients by promoting consistent quality in our treatments and developments.

At Sarepta, the work culture is supportive and dynamic, with a focus on wellness and work-life balance. The Associate Director, Pharmacovigilance Quality Assurance will find a collaborative atmosphere that encourages innovation and the sharing of ideas, all while committing to the mission of transforming genetic medicine.

The Associate Director, Pharmacovigilance Quality Assurance position at Sarepta presents ample opportunities for professional growth. You will engage in key compliance projects, mentor your team, and have a direct impact on shaping quality assurance practices within a leading biopharmaceutical company, enhancing your career in the process.

To ensure compliance and quality assurance in pharmacovigilance processes, I focus on establishing clear audit strategies, conducting regular training sessions, and continuously monitoring compliance metrics. This proactive approach helps maintain high standards and readiness for inspections.

My experience with regulatory inspections includes preparing audit documentation, managing risk assessments, and leading teams during inspections. I believe proper documentation and transparent communication are key factors in successfully navigating inspections.

I use a combination of data analytics, team collaboration, and internal audits to identify potential risks in pharmacovigilance. Upon identifying risks, I work on developing comprehensive mitigation strategies that involve corrective actions and preventive measures.

I stay updated with current regulations by subscribing to industry journals, attending relevant conferences, and participating in professional networks. Continuous learning allows me to adapt and ensure compliance with evolving guidelines.

When mentoring a less experienced team member in quality assurance, I focus on hands-on training, sharing practical examples, and encouraging questions. I aim to create a supportive environment that fosters their growth and confidence.

I find tools such as databases for tracking adverse events, audit management software, and compliance monitoring systems essential for managing pharmacovigilance quality. These tools streamline processes and facilitate efficient data management.

In one instance, we identified a significant compliance gap during an internal audit. I led a thorough investigation, collaborated with key stakeholders for quick remediation, and implemented a revised training program that addressed the root cause effectively.

I handle conflicts within my team by encouraging open communication and facilitating discussions to ensure all perspectives are heard. My goal is to reach a consensus that aligns with regulatory compliance and team goals.

I believe a strong compliance culture is built on transparency, accountability, and continuous education. By encouraging a culture of integrity, organizations create an environment where compliance is a shared responsibility of every team member.

To prepare for an upcoming audit in pharmacovigilance, I review historical audit findings, ensure that all documentation is up to date, conduct mock audits, and hold preparatory meetings with the team to discuss expectations and processes.