Associate Director, Patient Safety Scientist

AstraZeneca; Gaithersburg (MD); Híbrido; USD 132.000 - 199.000; Jornada completa

Descripción de la vacante

AstraZeneca plc is seeking an Associate Director, Cell Therapy Patient Safety Scientist to lead safety science activities within the Cell Therapy Patient Safety Unit, Global Patient Safety. This role integrates safety data from multiple sources, supports benefit‑risk decisions, and manages patient risks across the product lifecycle.

You will oversee pharmacovigilance components, generate safety reports (DSURs, PBRERs/PSURs), and contribute to regulatory submissions while mentoring junior

Formación

• Bachelor’s degree in life sciences, pharmacy, nursing or a related discipline with relevant experience.
• Substantial pharmaceutical, biotechnology or CRO experience in patient safety/pharmacovigilance and drug development, with experience independently delivering safety-science activities.
• Experience in at least three of the following: clinical development safety; signal management; periodic safety reports; risk-management plans; safety sections of protocols/IBs/ICFs/CSRs; regulatory responses; governance support.
• Good knowledge of US, EU and UK pharmacovigilance regulations and ICH guidelines.
• Experience with benefit-risk assessment, safety databases, MedDRA coding/search strategies and interpretation of data from multiple sources.
• Strong analytical, problem-solving, project-management, scientific writing and communication skills, with the ability to work effectively in a global matrix.
• Practical experience using large language models and agentic AI tools for scientific or safety work, including prompt/agent design, workflow automation, human oversight, validation, traceability, data privacy and critical verification of outputs.

Responsabilidades

• Conduct and coordinate safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets; develop MedDRA search strategies with appropriate guidance.
• Translate emerging safety data into clear analyses and recommendations for asset teams, escalating complex or high-impact issues to the GSPL and Patient Safety Physician.
• Lead defined components of pharmacovigilance and risk‑management planning, including RMPs, REMS, risk‑minimization tracking and benefit‑risk assessments.
• Author and project‑manage aggregate reports and safety deliverables, including DSURs, PBRERs/PSURs, PADERs, RMPs, REMS and ad hoc analyses.
• Author and coordinate safety content for protocols, Investigator Brochures, Reference Safety Information, informed consent forms, clinical study reports, Data Monitoring Committee materials and core data sheets.
• Support safety contributions to submissions and health‑authority responses, including NDA/BLA and MAA packages, and participate in inspections and regulatory interactions as assigned.
• Coordinate and contribute to SSaMT/Safety Surveillance Team activities, prepare governance materials, and present analyses to SIRC or other governance bodies as appropriate.
• Represent the Cell Therapy Patient Safety Unit on program and cross‑functional teams, ensuring agreed safety actions are documented and delivered.
• Contribute safety expertise to third‑party agreements and partnerships, supporting clear accountabilities and compliant safety processes.
• Provide day‑to‑day guidance, training and coaching to junior safety scientists, fellows and colleagues in relevant safety processes.
• Contribute to process improvements, standard procedures, templates and quality‑control practices for safety analytics and reporting.
• Apply agentic AI and other AI tools to approved safety workflows, including literature and data synthesis, document authoring support and workflow automation, while maintaining human oversight, validation, traceability, confidentiality and output verification.
• Partner with digital and data‑science colleagues to test, document and improve approved agentic AI workflows and reusable prompts/agents.
• Support additional Patient Safety priorities as directed by the line manager.

Conocimientos

Safety science

Pharmacovigilance

Data analysis

AI tools

Project management

Scientific writing

English language

Educación

Bachelor's degree in life sciences

MSc/PhD/PharmD

Herramientas

MedDRA coding

Safety databases

Agentic AI workflows

Descripción del empleo

Work arrangement

On-site: 3 days in the office and 2 days working from home

This is what you will do

The Associate Director, Cell Therapy Patient Safety Scientist is an experienced safety scientist within the Cell Therapy Patient Safety Unit, Global Patient Safety (GPS). The role leads defined safety science activities for assigned cell therapy assets, working with the Global Safety Program Lead (GSPL), Patient Safety Physicians and cross-functional partners. The Associate Director integrates safety data from multiple sources, supports benefit-risk decisions, delivers high-quality safety documentation, and helps manage patient risks across the product lifecycle.

You will be responsible for

• Conduct and coordinate safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets; develop MedDRA search strategies with appropriate guidance.
• Translate emerging safety data into clear analyses and recommendations for asset teams, escalating complex or high-impact issues to the GSPL and Patient Safety Physician.
• Lead defined components of pharmacovigilance and risk‑management planning, including RMPs, REMS, risk‑minimization tracking and benefit‑risk assessments.
• Author and project‑manage aggregate reports and safety deliverables, including DSURs, PBRERs/PSURs, PADERs, RMPs, REMS and ad hoc analyses.
• Author and coordinate safety content for protocols, Investigator Brochures, Reference Safety Information, informed consent forms, clinical study reports, Data Monitoring Committee materials and core data sheets.
• Support safety contributions to submissions and health‑authority responses, including NDA/BLA and MAA packages, and participate in inspections and regulatory interactions as assigned.
• Coordinate and contribute to SSaMT/Safety Surveillance Team activities, prepare governance materials, and present analyses to SIRC or other governance bodies as appropriate.
• Represent the Cell Therapy Patient Safety Unit on program and cross‑functional teams, ensuring agreed safety actions are documented and delivered.
• Contribute safety expertise to third‑party agreements and partnerships, supporting clear accountabilities and compliant safety processes.
• Provide day‑to‑day guidance, training and coaching to junior safety scientists, fellows and colleagues in relevant safety processes.
• Contribute to process improvements, standard procedures, templates and quality‑control practices for safety analytics and reporting.
• Apply agentic AI and other AI tools to approved safety workflows, including literature and data synthesis, document authoring support and workflow automation, while maintaining human oversight, validation, traceability, confidentiality and output verification.
• Partner with digital and data‑science colleagues to test, document and improve approved agentic AI workflows and reusable prompts/agents.
• Support additional Patient Safety priorities as directed by the line manager.

You will need to have

• Bachelor’s degree in life sciences, pharmacy, nursing or a related discipline with relevant experience, or an advanced degree with relevant experience.
• Substantial pharmaceutical, biotechnology or CRO experience in patient safety/pharmacovigilance and drug development, with experience independently delivering safety‑science activities.
• Experience in at least three of the following: clinical development safety; signal management; periodic safety reports; risk‑management plans; safety sections of protocols/IBs/ICFs/CSRs; regulatory responses; governance support.
• Good knowledge of US, EU and UK pharmacovigilance regulations and ICH guidelines.
• Experience with benefit‑risk assessment, safety databases, MedDRA coding/search strategies and interpretation of data from multiple sources.
• Strong analytical, problem‑solving, project‑management, scientific writing and communication skills, with the ability to work effectively in a global matrix.
• Practical experience using large language models and agentic AI tools for scientific or safety work, including prompt/agent design, workflow automation, human oversight, validation, traceability, data privacy and critical verification of outputs.
• Fluent written and verbal English.

We would prefer you to have

• MSc, PhD, PharmD or equivalent advanced degree in immunology, autoimmune disease, pharmacology or a related discipline.
• Experience in immunology research or drug development and in cell and gene therapy product development.
• Experience with clinical and safety databases, pharmacoepidemiology, real‑world evidence or quantitative safety methods.
• Experience supporting regulatory submissions, inspections or health‑authority responses.
• Experience configuring or evaluating an agentic AI workflow in a regulated scientific environment.
• Knowledge of pharmacovigilance regulations beyond the US, EU and UK.

Working environment

The duties of this role are generally conducted in an office environment. Employees must be able, with or without reasonable accommodation, to use a computer; communicate by phone, video and electronic messaging; engage in analysis, problem‑solving and dialogue; collaborate with others; and maintain general availability during standard business hours.

Why AstraZeneca?

At AstraZeneca, we work together to push the boundaries of science and deliver life‑changing medicines. You will join an inclusive, collaborative environment that values integrity, continuous learning and diverse perspectives, with the opportunity to shape the future of cell therapy safety and responsible AI‑enabled safety science.

Cell Therapy

The annual base pay for this position ranges from $132K to $199K. Our positions offer eligibility for multiple incentives an opportunity to receive short‑term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.