At AstraZeneca we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Patient Safety Specialist, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
The US Patient Safety Specialist serves as a Medical and Safety resource for synthesis, analysis, evaluation, and reporting of adverse event information in order to maintain an accurate safety profile of AstraZeneca products. The US Patient Safety Specialist serves as vital link in the timely classification, analysis and summarization of both investigational and post-marketed adverse event information and support to the product teams. The US Patient Safety Specialist supports the multidisciplinary teams and other cross-functional teams within AstraZeneca to provide case handling and safety support to licensing agreements, clinical study agreements and special projects
Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field, to include at least 2 years of Patient Safety experience
Participates in the triage process and data entry for incoming documents to insure timely and effective medical and scientific evaluation of adverse event information
Request follow-up information from consumers, and health care professionals and requests clarification from foreign affiliates according to specific report types using both global and local SOP timeframes
Reviews adverse event documents prepared by the Patient Safety personnel for accuracy, completeness, and validity prior to submission to the FDA
Enter and maintain accurate tracking system for all AE reports (Jasper)
Have a broad understanding of Support & Surveillance activities and the impact on individual case or group of cases can have on product labelling
Leads team in preparing, organizing, and reviewing tabulations for Regulatory reports
Represents US Patient Safety in Licensing Agreement review and process teams
Represents US Patient Safety for Clinical Trial protocol and safety handling plan review and process teams
Assumes responsibility for completing special projects (i.e. CIPs, representation on cross functional teams)
Supports Safety Surveillance, Safety Support - Compliance and Marketing Company and US Medical Affairs and the US Clinical Teams
Subject Matter Expert in PV related activities - Case Handling, FDA regulations, ICH/GCP guidelines and EU regulations
Serves as a knowledge resource for departmental personnel regarding medical, scientific and Operational issues
Demonstrates effective leadership, communication and project management skills including issue and risk management as well as the ability to collaborate and lead cross-functional PV related projects
Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries, collection of safety data and FDA / AZ processes and regulations
Drives continuous process improvements within Patient Safety
Reflects the Patient Safety philosophy of being a team player and supports the development of those individuals within the department
Working knowledge of technology required for Patient Safety
Excellent knowledge of FDA and ICH guidelines and reporting requirements
Initiates and volunteers for special projects
Demonstrated ability to perform with minimal supervision
Demonstrates leadership capabilities at target level or above
Ability to travel domestically for yearly business meeting
The Senior Specialist must, in addition, meet the following requirements:
Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare
related field, to include at least 3 years of Patient Safety experience
Works as a team player and supports the development of other team members
Excellent knowledge of FDA regulations and ICH guidelines
Provides training and mentoring of Patient Safety staff on local and global adverse event reporting, project work and with respect to career development
Demonstrates leadership ability by conducting team meetings independently and managing special projects
Assumes a lead role in identifying Patient Safety related issues and is instrumental in implementing solutions to those issues
Assumes back-up support for the Patient Safety Operations Manager/Director to meet/maintain departmental objectives
Assumes a lead role in supporting the business unit needs and Patient Safety by actively developing and maintaining partnerships with internal and external customers
Serves as a Patient Safety representative on various local, global and clinical teams
Supports the Patient Safety Operations Managers in performance management review of team members
Assumes a lead role in the interview process for prospective new team members
Demonstrates an active interest in pursuing continuing education within the Pharmaceutical Industry
Education:
Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background.
Required:
Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field, to include at least two years' experience in Patient Safety
Demonstrated working knowledge of FDA and ICH regulations relevant to Patient Safety and adverse event reporting
Broad competence with medical, therapeutic and technical terminology
Able to work effectively as part of a cross functional team
Excellent verbal and written communication skills
Demonstrated capabilities in;
Project management
Time management
Presentation skills
Strong attention to detail and organization
Preferred:
Bachelor's Degree.
Professional qualification • Project Management experience
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
