Patient Safety Hub Associate Director
AstraZeneca has a bold aspiration to improve the lives of 200 million patients by delivering 20 new medicines by 2030. We are committed to enhancing our customer focus and support critical functions across the entire Enterprise through our Global Business Services (GBS).
As the Patient Safety Hub Associate Director based in Guadalajara, you will play a key role in leading and managing our Patient Safety functions. You will ensure the timely and accurate processing and reporting of local adverse event cases while actively contributing to AstraZeneca's long-term ambitions.
Accountabilities & Responsibilities:
Regulatory Compliance:
Ensure adherence to global regulatory requirements, including timely submission of various regulatory reports.
Serve as a subject matter expert during audits and inspections related to case intake processes.
Leadership & Team Management:
Lead the Case Intake Team Managers and oversee team performance, providing guidance and training to ensure high-quality standards.
Maintain appropriate staffing levels and oversee recruitment of new staff.
Service Delivery & Process Improvement:
Oversee daily operations, ensuring efficient processing and reporting of adverse event cases.
Monitor case intake metrics, prepare KPI reports, and identify areas for improvement.
Implement standard operating procedures (SOPs) for case intake and processing.
Relationship Management:
Collaborate with other GBS Patient Safety Hub Directors and teams to improve processes and share standard methodologies.
Work closely with internal collaborators to align and enhance services in support of wider GBS goals.
Key Relationships:
Internal: Collaborate with Bangalore/Lisbon Hub Facilities Team, R&D Functional Teams, Global Business Services, and other internal stakeholders.
External: Engage with external service providers, healthcare professionals, health authorities, and professional societies.
Qualifications:
Minimum of 5-7 years in pharmacovigilance, including at least 3 years in a leadership role.
In-depth knowledge of global and regional pharmacovigilance regulations and key industry standards.
Exceptional attention to detail, strong analytical and problem-solving capabilities.
Excellent leadership and team management skills in a multicultural setting.
Outstanding communication skills, both written and verbal, in English.
Desirable:
Higher Degree (MBA, PhD) in a relevant field.
Proficiency in safety databases, ideally Argus.
Experience in delivering wide-scale transformation projects
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 the impact we can have on patients' lives. Our commitment to transformative science and innovative solutions ensures that we are always at the forefront of delivering life-changing medicines. We foster an inclusive environment where diverse perspectives are valued, and collaboration is key. Here, you will find opportunities for growth, development, and making a real difference.
Ready to make a meaningful impact? Apply now and join us on our journey!