AstraZeneca Pharmaceuticals LP Senior Patient Safety Specialist in Wilmington, Delaware
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. As a member of the Compliance Excellence team the Senior Patient Safety Specialist will be responsible for coordinating the lifecycle management of pharmacovigilance processes and technology, delivering centrally managed provision of services such as document management while meeting local regulatory requirements, and participating in research projects.
Main Duties and Responsibilities
In the role of Senior Patient Safety Specialist, you will lead and/or conduct a wide range of pharmacovigilance activities of multifaceted scope and complexity on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, processes and guidelines.
You will provide support to the Team Leader, or designee, in implementing various pharmacovigilance strategies, facilitating meetings and/or managing projects. Lead and/or provide oversight of local and global (as required) compliance data for adverse event reporting. Lead the analysis and trending of compliance data and communicate to customers monthly or more frequently as required. Lead the monitoring of compliance with local and global procedural documents, licensing agreements and regulations. Lead in-depth quality reviews of data, reports and regulatory submissions. Drive and implement guidance on inspection preparedness.
You will manage, support, and optimize the compliance safety meetings process for the region. Will carry out root cause analyses for reports that are late to regulatory authorities and/or licensing partners. Be responsible for alerting senior management of any possible deficiencies in quality and compliance standards and work with internal staff and external vendor and business partners to agree on corrective and preventative action. Lead personnel indirectly (as appropriate) within their respective area.
Must possess a Bachelor’s Degree along with 4 years of Pharmacovigilance and/or Clinical Development experience
Minimum of 4 years of pharmacovigilance department experience to include knowledge of pharmacovigilance compliance and practices, including a solid understanding of FDA and other Health Authority, and ICH regulatory requirements, guidance and obligations
Proven analytical skills
Proven leadership skills
Demonstrated ability to work independently and effectively in a cross-functional team environment with ability to work across cultures
Demonstrated ability to manage multiple competing assignments and timelines
Fluent in English language with excellent communication skills, both oral and written
Demonstrated ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
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.