Job Title: Director, QPPV Pharmacovigilance (PV) Process Oversight

Introduction to role:
Are you ready to lead and innovate in the realm of Patient Safety Regulatory Intelligence? As the Director, QPPV Pharmacovigilance (PV) Process Oversight, you will be at the forefront of ensuring compliance and excellence within our Quality Management System. Based in either Barcelona or Bangalore, you will coordinate with PS Business Process Owners to implement impactful changes and oversee processes that drive QPPV and PV excellence. Your expertise will elevate good practices and metrics, while you collaborate with cross-functional teams to design and document processes. This role also positions you as a key backup to the PS Global Business Process Area Lead and Business Learning Lead, ensuring continuity and leadership in our dynamic environment.

Accountabilities:
- Lead and serve as the subject matter expert for the Regulatory Intelligence process globally.
- Develop procedural documents, process maps, forms, templates, and other documentation for allocated processes within QPPV and PV excellence.
- Monitor business process or regulatory changes impacting SOP documentation and recommend appropriate actions.
- Consult with Patient Safety colleagues and cross-functional partners to provide expertise on SOP and process implementation.
- Collaborate with PS BPOs and subject matter experts to design and document processes.
- Support audits and inspections.
- Govern quality management of the GPS Procedural framework.
- Coordinate the Patient Safety Procedural Governance Team (PGT) by shaping agendas and driving effective pre-work.
- Act as backup for the Patient Safety Business Process Area Lead and Business Learning Lead.
- Drive continuous improvement of process management and oversight with BPOs and 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 complex projects
- Strong communication skills including demonstrated ability to influence effectively and implement change in complex matrix organizations

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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll be part of a team that pushes the boundaries of science to transform patient outcomes. Our collaborative environment fosters innovation, empowering you to take smart risks and challenge norms. With one of the broadest Oncology pipelines in the industry, you'll have opportunities to work with novel drugs and make a real impact. We believe in growing together, providing a space where diverse perspectives are valued, and everyone has a voice. Join us in our mission to eliminate cancer as a cause of death.

Ready to make a difference? Apply now and be part of our journey to transform lives through science!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.