Associate Director, Patient Safety Scientist at AstraZeneca
Job ID: R-211222
Date Posted: 10/21/2024
Global Career Level: E
Introduction to Role
Join AstraZeneca as an Associate Director, Patient Safety Scientist. In this role, you'll collaborate with the Global Safety Physician (GSP) and Senior Patient Safety Scientist to review safety data and documents for potential safety issues. You'll be responsible for authoring pharmacovigilance input for safety documents and regulatory reports, as well as leading meetings and presenting safety data.
Accountabilities
Proactive Pharmacovigilance: Lead risk management planning for designated products, including the preparation of safety aspects of Global Risk Management Plans.
Cross-Functional Representation: Act as the Patient Safety representative on project teams for marketed products and developmental compounds.
External Presentations: Present safety information at external meetings.
Data Evaluation: Lead discussions on safety data evaluation within the Safety Information Review Committee (SIRC).
Safety Information Collaboration: Collaborate with GSP and Clinical representatives to author Reference Safety Information (RSI) for products.
Clinical Evaluation: Proactively assess clinical implications of safety data to establish safety profiles and manage patient risk.
Regulatory Document Preparation: Author and provide input for periodic regulatory documents (PBRERs, PSURs, DSURs).
Training and Mentoring: Train junior team members on Patient Safety tools and systems.
Essential Skills/Experience
Educational Background: Degree in biosciences or a related healthcare field, with proven competency in patient safety and clinical development.
Regulatory Knowledge: Comprehensive understanding of Patient Safety regulatory obligations and policies.
Experience: 9 to 11 years in Patient Safety, totaling 12 to 14 years of relevant experience.
Communication and Leadership Skills
Interpersonal Skills: Strong interpersonal skills and cultural sensitivity.
Strategic Thinking: Ability to adapt approaches based on broad perspectives.
Decisive Action: Make effective decisions under pressure and seek support when necessary.
Performance-Driven: Hold the team accountable to quality standards and clarify objectives.
Why AstraZeneca?
At AstraZeneca, we’re dedicated to advancing science to transform patient care. Join our pioneering team to help eliminate cancer as a cause of death. We foster a collaborative environment that encourages smart risks, challenges norms, and values diverse perspectives.
Ready to Make a Difference?
If you’re ready to bring fresh thinking and innovative ideas, we want to hear from you!
Explore More About Us:
AstraZeneca embraces diversity and equality of opportunity. We welcome applications from all qualified candidates and comply with all applicable laws and regulations on non-discrimination in employment.
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