# Director, Senior Patient Safety Scientist at AstraZeneca

AstraZeneca is hiring a Director, Senior Patient Safety Scientist. It pays $203k-$305k a year and Level rates it Little AI ●○○○; you can [apply on AstraZeneca](https://jobsbylevel.com/go/55f35c0c-6f03-4593-bd66-3b282b492cd6?utm_medium=ai-agent).

AI Level 1, AI centrality 28 out of 100. US - Gaithersburg - MD.

## Details

- Company: [AstraZeneca](https://jobsbylevel.com/companies/astrazeneca)
- AI level: AI Level 1 (score 28 out of 100)
- Location: US - Gaithersburg - MD
- Salary: $203k-$305k
- Posted: November 9, 2026
- Apply: https://jobsbylevel.com/go/55f35c0c-6f03-4593-bd66-3b282b492cd6?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=director-senior-patient-safety-scientist-at-astrazeneca-9ec1c8

## Description

This is what you will do The Director, Cell Therapy Patient Safety Scientist is a senior scientific leader within the Cell Therapy Patient Safety Unit, Global Patient Safety (GPS). The role leads safety science strategy and delivery for multiple and/or complex cell therapy assets, working with the Global Safety Program Lead (GSPL), Patient Safety Physicians and cross-functional partners. The Director integrates clinical, nonclinical, epidemiologic and real-world evidence to shape safety profiles, guide benefit-risk decisions, support governance and regulatory interactions, and protect patients across the product lifecycle. You will be responsible for Lead safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets; define and document appropriate MedDRA search strategies. Set the safety science strategy for multiple, complex or high-priority assets and translate emerging data into clear recommendations for governance and development teams. Lead proactive pharmacovigilance and risk-management planning, including Global Risk Management Plans, REMS, risk-minimization measures and benefit-risk assessments. Provide strategic leadership and oversight for aggregate reports and safety deliverables, including DSURs, PBRERs/PSURs, PADERs, RMPs, REMS and ad hoc analyses. Lead safety content and strategy for protocols, Investigator Brochures, Reference Safety Information, informed consent forms, clinical study reports, Data Monitoring Committee materials and core data sheets. Lead safety contributions to major submissions and health-authority responses, including NDA/BLA and MAA packages, and represent Patient Safety in inspections and complex regulatory interactions. Chair or lead safety forums and cross-functional discussions, including SSaMT/Safety Surveillance Team activities and presentations to SIRC or other governance bodies. Serve as a senior Patient Safety representative on global program and cross-functional teams; influence development strategy through scientifically grounded, patient-focused recommendations. Lead or advise on safety provisions in third-party agreements and partnerships, ensuring scientific quality, clear accountabilities and regulatory compliance. Mentor safety scientists, build capability across the function and provide expert training in cell therapy safety, pharmacovigilance methods and benefit-risk assessment. Sponsor process improvements and functional standards for safety analytics, reporting, governance and regulatory readiness. Define and oversee responsible use of agentic AI in safety workflows, including use-case selection, human-in-the-loop controls, validation, traceability, data protection, output verification and benefit realization. Partner with digital, data science, clinical and regulatory colleagues to scale validated agentic AI solutions and establish fit-for-purpose governance and performance measures. 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 substantial relevant experience, or an advanced degree with relevant experience. Extensive pharmaceutical, biotechnology or CRO experience in patient safety/pharmacovigilance and drug development, including leadership of complex safety or scientific activities. Proven experience setting program-level safety strategy and leading at least three of the following: early/late clinical development; NDA/BLA or MAA submissions; periodic safety reports; risk-management plans; signal management; governance interactions; health-authority responses. Strong knowledge of US, EU and UK pharmacovigilance regulations and ICH guidelines; ability to interpret evolving requirements and define an organizational response. Demonstrated leadership in benefit-risk assessment, scientific communication, matrix influence, decision-making under uncertainty and management of multiple

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Source: https://jobsbylevel.com/jobs/director-senior-patient-safety-scientist-at-astrazeneca-9ec1c8

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