Patient Safety Operations Specialist

Job Title: Patient Safety Operations Specialist

Location: Onsite with Flexibility in Wilmington DE OR Gaithersburg MD

Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

What you’ll do

As a US Patient Safety Operations Specialist, you will be primarily responsible for providing pharmacovigilance support to AZ Brand teams that are conducting Patient Support Programs and Market Research support. The Patient Safety Operations Specialist will ensure business continuity for pharmacovigilance processes and systems and deliver a centrally managed provision of services such as document management while meeting local regulatory requirements.

In this role, the Patient Safety Operations Specialist will:

• Lead and/or provide support for pharmacovigilance outsourcing activities through identification, selection, negotiation, and/or management and maintenance of current Good Pharmacovigilance Practices (cGVP) and required pharmacovigilance activities in assigned projects.
• Lead, review and/or contribute to pharmacovigilance oversight of US Commercial and Market Research programs to ensure adverse event reporting compliance.
• Conduct training in both classroom and individualized settings in the process of training, mentoring and coaching junior members of the team.
• Demonstrate the ability to present information to both internal and external stakeholders.
• Review safety data output for accuracy and completeness prior to submission to internal and external sources.
• Review and contribute to the development, improvement and validation of procedures, policies, processes, guidelines and/or systems for the pharmacovigilance components of various activities. Ensure all procedural documents are compliant with organizational standards, are aligned with targeted roles, and ensure non-compliant processes are escalated.
• Develop and execute user acceptance test scripts per company SOPs to confirm the functionality of Patient Safety applications.
• Lead and/or drive the negotiation of adverse event language with 3rd party vendors.
• Liaise as necessary with cross-functional teams and provides consult during development of US Commercial and Market Research programs to determine if they will generate adverse event data, and if so, to ensure that the appropriate measures and/or language are in place to account for the generation of such data.
• Maintain knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development.
• Provide oversight for the development, implementation and management of adverse event training content for employees and suppliers.
• Lead and/or conduct a wide range of multifaceted scope and complex pharmacovigilance activities on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, processes and guidelines.
• Serve as a knowledge resource to Patient Safety staff as well as to personnel in areas outside of Patient Safety with a deep understanding of organizational global and local procedural documents and local implementation of objectives, policies, processes and procedures and regulatory requirements, guidelines and obligations relevant to pharmacovigilance activities and adverse event reporting.
• Lead, review and/or contribute to the maintenance of US Commercial and Market Research programs.
• Lead and/or provide support to the pharmacovigilance component of contracts/agreements with third parties to ensure quality and integrity of agreement.
• Support a performance-driven culture.
• Provide support to team leadership in implementing various pharmacovigilance strategies
• Conduct activities and interactions consistent with organizational values and behaviors and in compliance with AstraZeneca’s Code of Conduct and supporting policies and standards relevant to the role. Complete all required training on the Code of Conduct and supporting policies and standards within established timeframes. Report potential issues of non-compliance.

Essential for the role

• 2-4 years of Pharmacovigilance and/or clinical development experience, with a minimum of 4 years of pharmacovigilance department experience to include knowledge of pharmacovigilance practices, including a solid understanding of FDA ((including but not limited to 21 CFR part 312.32 (Investigational New Drug Application), 21 CFR part 314.80 (Post marketing reporting of adverse drug experience) and 21 CFR part 600.80 (Biological Products)) and other Health Authority (such as EU Good Pharmacovigilance Practices Modules) , and ICH regulatory requirements, guidance and obligations.
• Bachelor Degree in Biosciences (equivalent healthcare or pharmaceutical industry background in lieu of focus in Biosciences).

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.