Safety Liaison

Job Summary The China (senior) PV Specialist is responsible for safety data management and submission, PV system management, providing training to AZ staffs and/or vendors and to be the partner with cross-functional team and external customers. This role should understand company’s code of conducts& compliances policies& China PV Regulations, and to manage the daily activity to align with these accordingly. DUTIES & RESPONSIBILITES / 主 要 职 责 ICSR (individual case safety report) management Individual AE report handling, from all sources: clinical studies, spontaneous, literatures, etc: - Data review, coding, translation and communication - Report to global Data entry site - Report to CFDA - Query answering - Tracking and archiving - Late case communication and CAPA report CFDA batch case handling - Data review, coding, translation or validation - Report to global Data entry site - Query solving - Case synchronization Internal/vendor case QC - Data entry accuracy, integrity and timeliness - Documentation archived completeness and timeliness - Case tracking log accuracy and timeliness - CIOMS download and clean up timely - Global Data entry site queries respond timely - ADR system queries response timely - Late case communication and CAPA report accomplish Generate routine and ad hoc reports to support pharmacovigilance activities and regulatory reporting requirements. Vendor management Be back up for team members Periodic Safety reports management Monthly Line Listing submission - Translation validation - Upload to ANGEL - Submission - Tracking and archiving Study SUSAR Line Listing - Translation validation - Upload to ANGEL - Submission - Tracking and archiving Distribute safety information to study management team and keep tracking. PSUR/PBRER submission - Translation validation - Upload to ANGEL - Submission - Tracking and archiving Patient Safety quality compliance Monthly AE reconciliation with cross functional team which has interaction on AE reporting Review and Operational input of Licensing, Clinical Safety Agreements and SHP (safety handling plan) Work with business partner to ensure business activities (e.g. Market Research and Patient-Centric programs) to determine operational pharmacovigilance requirements (contracts, training, issue resolution) ensuring compliance with regulations Training Deliver safety training to ensure full safety compliance AE awareness training to new staffs AE awareness training to vendors Refresh training to the staffs who has stay in AZ more than 1 year AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. Date Posted 15-4月-2024 Closing Date 14-7月-2024 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.