The patient is at the heart of everything we do. The guiding light for all our actions and decisions. Our teamwork sets us apart and keeps us leading the way, often at an intense pace. There’s never a dull moment in BioPharmaceuticals Medical.

Be part of changing the practice of medicine forever. A place to be at the forefront; proactive, innovative and brave, we don’t stop. It means we dare to do the big studies in the real world, utilizing primary and secondary data, leading the field in evidence generation and external scientific engagement. We have an opportunity to see how the compelling medical evidence we generated and communicated influences the basis of future healthcare.

As a member of the US Patient Safety Compliance Management or Quality & Enablement (Business Support or Systems Enablement team) Section, is primarily responsible for coordinating the lifecycle management of pharmacovigilance processes and technology. Develops reporting tools and analysis processes and technology to identify improvements. Ensures business continuity for pharmacovigilance processes and systems. Delivers a centrally managed provision of services such as document management while meeting local regulatory requirements. Can solve moderate to sometimes multifaceted scope and complex problems within own area and will participate in research projects.

What You'll Do

• Conducts 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. Completes all required training on the Code of Conduct and supporting policies and standards within established timeframes. Reports potential issues of non-compliance.
• Conducts and/or supports a wide range of moderate to sometimes 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.
• Demonstrates a solid working knowledge of organizational procedural documents (global and local) and ensures local implementation of objectives, policies, procedures, regulatory requirements, and obligations relevant to pharmacovigilance activities and adverse event reporting, including periodic safety reporting.
• Reviews and contributes to the development, improvement and validation of procedures, policies, processes, guidelines and/or systems for the pharmacovigilance components of various activities. Ensures all procedural documents are compliant with organizational standards, are aligned with targeted roles, and ensures non-compliant processes are escalated.

• Contributes to the scientific and/or technical contributions of new safety-related systems, processes and/or procedures within the US region.
• Contributes to the pharmacovigilance component of contracts/agreements with third parties to ensure quality and integrity of agreement.
• Leads and/or provides 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.
• Provides support to team leadership in implementing various pharmacovigilance strategies.
  • Contributes 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:
  • Analyzes information to determine project requirements and provides recommendations and solutions.
  • Reviews safety data output for accuracy and completeness prior to submission to internal and external sources.
  • Leads and/or supports specific activities in regulatory inspections and internal audits.
• Contributes to and/or represents the US region on specific Patient Safety Teams and workstreams.
  • Provides input to Information Systems/Information Technology (IS/IT) teams in the development, maintenance and support of various safety systems and related applications.
  • Develops and executes user acceptance test scripts per company SOPs to confirm the functionality of Patient Safety applications.
  • Provides detailed summary analysis to team leadership regarding team data, issues, trends, and actions taken.
  • Maintains knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development.
  • Demonstrates the ability to present information to both internal and external stakeholders.
  • Conducts training in both classroom and individualized settings.
  • Trains, mentors, and coaches junior members of the team.
  • Supports a performance-driven culture.

Essential for the Role

• Bachelor’s Degree in biosciences or an equivalent healthcare or pharmaceutical industry background.
• 2-4 years of Pharmacovigilance and/or clinical experience, with a minimum of 2 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.
• Prior pharmacovigilance experience in case handling (post-marketing and clinical), compliance or quality role in a Patient Safety department.
• Experience in quality management systems including compliance data analysis, trend analysis, root cause analysis and Corrective and Preventive Action mitigation plans.
• Experience with data collection, data analysis and data reporting.
• Experience with utilizing Business Objects and Spotfire reports (or equivalent) for data trend analysis is desirable.
• Experience in creation and management of procedural documents.
• Experience with continuous process improvement initiatives.
• Proven analytical skills.
• Proven leadership skills.
• Experience with Windows Operating system, Microsoft applications (e.g. PowerPoint, Excel, Word, and Internet Explorer), SharePoint, Box, Teams, and learning management systems.
• 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.
• Demonstrated ability to perform data analysis activities, including trending analysis, root cause analysis and implementation of CAPA plans
• Demonstrated ability to influence whilst maintaining independent and objective views.
• Demonstrated ability to maintain high ethical standards, including a commitment to organization values and behaviors.
• Detail oriented.

Desirable for the Role

• Advanced degree within field and/or professional certification (project management, Lean Six Sigma, ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/ Organizational Excellence, or SQA Registered Quality Assurance Professional.
• Experience with supporting internal/external audits, regulatory inspections (cGVP, cGMP, cGCP for pharmacovigilance related inquiries).
• Experience with development/maintenance of safety data exchange agreements and vendor management oversight activities.
• 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.

Location: Wilmington, DE

Our Wilmington campus is one of 30 production facilities in 18 countries that creates life-changing medicines for people around the world.  It is also the home of our North America Biopharmaceutical Business. It’s where several business functions integral to our US business are based and where 1,500 of our colleagues innovate for a higher purpose. Conveniently located near Philadelphia, our newly redesigned campus offers a positive and inclusive environment and plenty of on-site perks for employees.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

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

Where can I find out more?

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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.