Head of Pharmacovigilance and Regulatory Quality Assurance

Head of Pharmacovigilance and Regulatory Quality Assurance

Full-Time On-site
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The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system. You are the independent quality authority ensuring that our end-to-end PV processes across clinical safety, regulatory affairs, and medical affairs remain compliant with global regulations, ICH guidelines, and company standards. Your role bridges strategic oversight with hands on operational leadership: you design the audit strategy and governance framework that keeps the system fit for purpose, but you also own the day-to-day quality assurance of how PV actually works across the business. You will direct both the strategic evolution of the PVRQA function and its operational delivery. This means setting the long term compliance roadmap while simultaneously managing inspections, deviation management, and the practical quality controls that keep the system sound. You partner with senior leadership on strategic direction, but you're equally engaged in the details that matter—ensuring SOPs are fit for purpose, CAPA workflows are rigorous, and systems are inspection-ready The Role You will direct the strategic development of the Global PVRQA function, supporting both the global R deliver annual internal and external audit programs covering global systems, affiliates, and 3rd party vendors. Inspection an advanced degree is preffered Industry Tenure: 10+ years of pharmaceutical industry experience specifically within Quality Assuarance Leadership Track Record: Proven experience in a senior leadership capacity with deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines. Technical Mastery: Extensive understanding of end-to-end pharmacovigilance processes, including Deviation/CAPA management and the conduct of clinical research. Global Perspective: Experience working within global, cross-functional teams and managing complex regulatory interactions. Leadership Attributes Strategic Acumen: The ability to quickly analyze complex circumstances and drive appropriate decisions and actions. Communication

Head of Pharmacovigilance and Regulatory Quality Assurance employer: CSL

CSL Seqirus is an excellent employer that fosters a collaborative and inclusive work culture, making it an ideal place for a Global Financial Analyst. With a strong focus on employee growth and development, the company offers numerous opportunities for professional advancement while providing a hybrid working model that promotes work-life balance. Located in Speke, Liverpool, employees benefit from a vibrant community and the chance to engage with diverse teams across the globe, enhancing both personal and professional experiences.

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Contact Details:

CSL Recruitment Team