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 Senior Patient Safety Specialist in Wilmington, DE, you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. Main Duties and Responsibilities
This role will require you to provide support, guidance, and/or technical assistance as a member of the section’s Business Support, Compliance, or Information Services team(s) on a variety of pharmacovigilance activities of multifaceted scope and complexity to both mitigate risk to the business and support our license to operate.
You will be asked to lead a wide range of pharmacovigilance activities within established time frames to ensure compliance with Global and Local procedures, policies, processes and guidelines. You’ll serve as the knowledge resource with a deep understanding of these policies, processes and guidelines and report on internal and external adverse events to Patient Safety personnel. You’ll be challenged to lead or contribute to the development, improvement and validation of the guidelines in place and ensure they are compliant with AstraZeneca standards, while ensuring non-compliant processes are escalated.
Finally, as a part of the Compliance Team, you will lead analysis and trending of compliance data and communicate this to our customers regularly and work to lead the monitoring of compliance with local and global procedural documents, licensing agreements and regulations.
- Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background.
- 4-7 years’ experience in pharmaceutical industry, with at least 4 years of pharmacovigilance experience (with drug safety regulations (i.e., FDA, EMA, MHRA, etc.), and working in a pharmaceutical drug safety department.
- Proven analytical skills.
- Proven leadership skills.
- Able to work effectively in a cross-functional team environment with ability to work across cultures.
- Able to work independently, guided by procedures, with appropriate support.
- Ability to multitask across multiple assignments.
- Able to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas.
- Able to influence whilst maintaining independent and objective views.
- Excellent oral and written communication skills.
- Maintains high ethical standards, including a commitment to AstraZeneca values and behaviors.
- Solid attention to detail skills.
- Solid time management skills.
Computer literate. Desirable Requirements
Next Steps – Apply today!
- Experience with Safety Data Exchange Agreements (SDEA)
- 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.
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.