Patient Safety Specialist (Operations)
AstraZeneca

Job Title: Patient Safety Specialist (Operations)

Location: Onsite with Flexibility in Wilmington DE

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

Educational Requirement:

• Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background.

Required Knowledge, Skills and Experience

• 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: a) Project Management, b) Time Management, c) Presentation Skills, d) Strong attention to detail and organizational skills

Preferred Knowledge, Skills and Experience:

• Bachelor's Degree.
• Professional qualification and or credentials
• Project Management experience and or certification

AstraZeneca - An Employer of Choice

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 offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package! If you have what it takes to create a culture of courageous leadership, creativity and collaboration, please apply today!

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.

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 requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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