At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Patient Safety Specialist in Wilmington, DE, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
Main Duties and Responsibilities
In this role, you will provide support, and guidance as a member of the section’s Compliance team on a variety of pharmacovigilance activities of moderate to sometimes multifaceted scope and complexity to both mitigate risk to the business and support our license to operate. You will review and contribute to the development, improvement and validation of procedures, policies, processes, guidelines and/or systems for the pharmacovigilance components of various activities and ensures they are compliant with AstraZeneca standards and ensures non-compliant processes are escalated.
You’ll coordinate the collection of reasons for late adverse event reporting, conducts root cause analysis, corrective actions to prevent future late reporting, and trending analyses from clinical, regulatory and marketing and any other appropriate stakeholders for inclusion in safety reports to regulatory authorities within established timelines.
Finally, you’ll provide analysis and trending of local and global (as required) compliance data for adverse event reporting data and communicates to customers monthly and/or more frequently, as required. Monitors compliance with local and global procedural documents, licensing agreements and regulations. Supports and/or sometimes leads in-depth quality reviews of data, reports and regulatory submissions.
- Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background.
- 2-4 years’ experience in pharmaceutical industry, with at least 2 years of pharmacovigilance experience (with drug safety regulations (i.e., FDA, EMA, MHRA, etc.), and working in a pharmaceutical drug safety department.
- Advanced degree within the field and/or professional certification.
- Experience within the pharmaceutical industry and prior pharmacovigilance case handling or pharmacovigilance compliance or IS/IT experience in a Patient Safety department.
- Advanced knowledge of medical terminology, clinical terms, MedDRA, U. S. Code of Federal Regulations and global regulations regarding AE reporting.
- Advanced knowledge of pharmacovigilance processes, standards, conventions, and governance.
- Project management expertise.
- Regulatory audit/inspection experience.
- Experience with process improvement initiatives.
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.
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.