Senior Specialist Patient Safety

Introduction to role

Are you ready to make a difference in the world of patient safety? At AstraZeneca, we believe in the potential of our team and offer you the opportunity to develop beyond your expectations. As a Senior Specialist in Patient Safety, you'll play a crucial role in ensuring the safety and efficacy of our products throughout their lifecycle. Your mission will be to provide high-quality, comprehensive pharmacovigilance services, offering technical and scientific expertise to both internal and external stakeholders. Join us in safeguarding patients and contributing to the success of our business.

Accountabilities

• Collaborate with the Associate Director of Patient Safety on pharmacovigilance projects.
• Maintain compliance with procedural documents, legislation, and codes, ensuring an accurate personal training record.
• Support the delivery of the Patient Safety team's strategy across AZ Spain, overseeing safety-related processes and activities.
• Manage Quality System planning and recording, including change control and risk analysis related to GVP.
• Review procedural documents for pharmacovigilance projects as directed.
• Provide information necessary for the GVP area's license to operate.
• Liaise with third-party companies involved in licensing agreements, divestments, and acquisitions.
• Ensure local pharmacovigilance information is accurately reflected in the Pharmacovigilance System Master File (PSMF).
• Ensure compliance with AZ and regulatory requirements for patient safety, implementing corrective actions for non-compliance.
• Support data entry oversight into the local database (ARGUS) and assist with case assessments.
• Oversee AE follow-up activities to ensure timely responses to Healthcare Professionals, Patients, and other reporters.
• Organize Data Collection Programs such as Market Research, Non-Interventional Studies, Patient Support Programs, Digital assets, and Early access programs in Spain.
• Support PV awareness training for employees and vendors.
• Ensure a local Business Continuity Process (BCP) for Patient Safety is in place and tested annually.
• Participate in audits and inspections.

Essential Skills/Experience

• Life science degree, preferably pharmacist with a minimum of 2 years experience.
• Mandatory verbal and written English and Spanish skills.
• Demonstrable knowledge of the Quality Management System within pharmacovigilance.
• Knowledge of legislation governing pharmacovigilance in Europe/Spain.
• Experience working in pharmacovigilance at a marketing company level.
• Experience with external customer interaction.
• Ability to effectively influence and interact with cross-functional colleagues.

Desirable Skills/Experience

• Project management skills.
• Experience in implementing Risk Management Plans.

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, we are driven by curiosity and courage, constantly pushing the boundaries of science to pioneer new frontiers. Our commitment to oncology is fueled by an ambition to eliminate cancer as a cause of death. With cutting-edge science and technology, we aim to deliver breakthroughs that transform medicine. Our collaborative research community unites academia and industry, expediting research in challenging cancer treatments. Join us in making bold decisions that lead to impactful patient outcomes.

Ready to take on this exciting challenge? Apply now and be part of our journey!

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.