Director, QPPV Pharmacovigilance (PV) Process Oversight

Job Title: Director, QPPV Pharmacovigilance (PV) Process Oversight
Location: Warsaw, Poland (Hybrid model: 3 days from the office, 2 days from home)

Introduction to role

Are you ready to lead and innovate in the field of pharmacovigilance? As the Director of QPPV Pharmacovigilance Process Oversight, you will be at the forefront of ensuring patient safety through regulatory intelligence and process excellence. You will collaborate with Patient Safety Business Process Owners to assess and implement essential changes for compliance, while also maintaining and overseeing processes within the scope of QPPV and PV excellence. Your expertise in the AZ Quality Management System will elevate good practices and metrics, and you will coordinate the PS Procedural Governance Team to align expert pre-work with senior stakeholder endorsements. This role also serves as a backup to key leadership positions, contributing significantly to our mission of delivering life-changing medicines.

Typical Accountabilities

• Lead and serve as the subject matter expert for the Regulatory Intelligence process for Patient Safety globally.
• Develop procedural documents, process maps, forms, templates, and other documentation for allocated processes within QPPV and PV excellence.
• Monitor the impact of business process or regulatory changes on SOP documentation and recommend appropriate actions.
• Consult with Patient Safety colleagues, cross-functional partners, and external partners to provide expertise on SOP and process implementation recommendations.
• Collaborate with PS BPO and cross-functional subject matter experts to design and document processes.
• Support audits and inspections.
• Own and govern quality management of the GPS Procedural framework.
• Coordinate the Patient Safety Procedural Governance Team by shaping agendas and driving effective pre-work with senior collaborators.
• Act as a backup for the Patient Safety Business Process Area Lead and Business Learning Lead.
• Drive, oversee, and manage continuous improvement of process management and oversight with BPOs and Patient Safety leadership stakeholders.

Essential Skills/Experience

• Previous pharmaceutical, medical/clinical/laboratory or other scientific experience required
• Proven experience successfully leading cross-functional global teams in procedural document management, maintenance, and oversight
• Significant experience in managing multiple, highly sophisticated projects
• Strong interpersonal skills including demonstrated ability to influence effectively and implement change in complex matrix organisations

Desirable Skills/Experience

• Bachelor’s degree or higher (life sciences preferred)
• Minimum of 12-15 years (or equivalent industry experience) in a Drug Safety environment
• Prior experience with electronic documentation systems such as Veeva Vault®
• Prior experience with learning management systems
• Prior experience with leading a Regulatory Intelligence process

At AstraZeneca, we are driven by a passion for science and innovation. We are transforming how we discover and develop new medicines by integrating digital technology and data into every aspect of our work. Our commitment to improving patient experiences and outcomes is unwavering, as we embrace new approaches and insights. Join us in a dynamic environment where your skills will be combined with cutting-edge technology to drive innovation and make a significant impact on global healthcare.

Ready to take on this exciting challenge? Apply now to join our team at AstraZeneca!