We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, willing to collaborate, and curious about what science can do, then you’re our kind of person.

The Clinical Trial Safety Specialist  will work closely with the core study team (including the Clinical Development Manager & Study Physician) to ensure well-defined standards are outlined during study setup, and appropriate eCRF modules and Safety Monitoring agreements are in place. During the recruitment and maintenance phases of the clinical trial, he/she will use the Center’s data review tool to review and query important safety data such as Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), Adverse Events leading to Discontinuation (DAEs) and lab outliers. The CTSS will also support study teams via writing patient narratives for qualifying events (SAEs, AESIs, and DAEs). 

Requirements:

•    Advanced degree in a medical profession such as pharmacist, nurse, nurse practitioner, dentist, with pharmacovigilance background, or equivalent work experience in directly related fields 
•    Minimum two years of experience working on clinical studies and/or study safety methodology
•    Relevant industry or health care experience 
•    Proven organizational and analytical skills
•    Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities
•    Knowledge of SAE reporting requirements 
•    Clinical/medical background in nursing providing a stable knowledge base for reviewing SAEs and other safety event
•    Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information
•    Excellent knowledge of spoken and written English

Next step - 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.

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

Closing Date

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.