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.

In the BioPharmaceuticals Business Unit team we thrive in our diverse and vibrant environment. Part of a global research-led enterprise, there’s always novel science to bring to market. It brings out the best in us – provided with all the support and tools needed and the agility to move fast. Unleash your ambition and your true self. Part of our inclusive environment where there’s opportunity for global mobility, continuous learning and building best practices.

What you’ll do

As a member of the US Patient Safety Quality & Enablement Business Support team, you will be primarily responsible for providing pharmacovigilance support to AZ Brand teams that are conducting Patient Support Programs and Market Research support.  The Sr. Patient Safety 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 Sr. Patient Safety Specialist will:

• 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.
• 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 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.

• Lead, review and/or contribute to the maintenance of US Commercial and Market Research programs.
• 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.
• Lead, review and/or contribute to pharmacovigilance oversight of US Commercial and Market Research programs to ensure adverse event reporting compliance.
• Lead and/or drive the negotiation of adverse event language with 3rd party vendors.
• Provide oversight for the development, implementation and management of adverse event training content for employees and suppliers.

• 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.
• Lead and/or provide support to the pharmacovigilance component of contracts/agreements with third parties to ensure quality and integrity of agreement.
• 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.
• Provide support to team leadership in implementing various pharmacovigilance strategies
• Lead personnel indirectly (as appropriate) within their respective area.
• Contribute to the quality management framework, by conducting thorough investigations and documenting high quality incident reports into the quality management system in order to minimize future risk.

• Analyze information to determine project requirements and provides recommendations and solutions.
• Review safety data output for accuracy and completeness prior to submission to internal and external sources.
• Lead and/or support specific activities in regulatory inspections and internal audits.

• Contribute to and/or represent the US region on specific Patient Safety Teams and workstreams.
• Provide input to Information Systems/Information Technology (IS/IT) teams in the development, maintenance and support of various safety systems and related applications.
• Develop and execute user acceptance test scripts per company SOPs to confirm the functionality of Patient Safety applications.
• Provide detailed summary analysis to team leadership regarding team data, issues, trends, and actions taken.
• Maintain knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development.
• Demonstrate the ability to present information to both internal and external stakeholders.
• Conduct training in both classroom and individualized settings.
• Train, mentor, and coach junior members of the team.
• Support a performance-driven culture.

Essential for the role

• Bachelor Degree in Biosciences (equivalent healthcare or pharmaceutical industry background in lieu of focus in Biosciences).
• 4-8 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.

Why AstraZeneca?

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.

With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.

So, what’s next!

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

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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.