New · posted Nov 10
AstraZeneca · Pharmaceuticals
Associate Director, Patient Safety Scientist
- Gaithersburg, MD
- Hybrid
- Full-time
- Director
The role
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.
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.
What you need
What you'll do
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.
Pay and benefits
$132,000 – $199,000 a year
Employer providedSo, what's next?
Are you ready to bring your safety-science expertise to our team? We look forward to hearing from you.
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.
Qualified retirement programs
Paid time off
Health, dental and vision coverage
Short-term incentive bonuses
Equity-based awards
Where you'll work
Gaithersburg, MDHybridOpen in Maps (opens in a new tab)
More jobs in Gaithersburg, MDWorking conditions
Work arrangement
On-site: 3 days in the office and 2 days working from home
From the posting
About AstraZeneca
Date Posted
09-Nov-2026
Closing Date
29-Nov-2026
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.
Equal opportunity, accessibility and legal noticesAstraZeneca's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 36% below the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Director roles in the US82 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $132,000 | — | $199,000 |
| All US (middle half) | $223,125 | $258,250 | $278,500 |
This role: AstraZeneca's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 157 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not AstraZeneca's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs9
- Collaboration and leadership8
- GMP and compliance4
- Lab testing and methods3
- Validation and qualification3
- Quality systems and risk3
- Clinical trial conduct3
- Regulatory submissions2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Safety & Pharmacovigilance work in pharmaceuticals, led by the three this posting names, each linked to the agency or standards body that publishes it.
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical historyNamed in the posting
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concernsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA good pharmacovigilance practices(official source, opens in a new tab)Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
- FDAFDA FAERS(official source, opens in a new tab)The FDA Adverse Event Reporting System for drugs and biologics
- EMAEU Good Pharmacovigilance Practices (GVP)(official source, opens in a new tab)EMA's modules for pharmacovigilance systems, signals and periodic reports
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
AstraZeneca on Regulatory Jobs
- 44
- Open roles
- 44
- Distinct roles
- 10
- Locations
By discipline
- Clinical18 41%
- Quality14 32%
- Regulatory12 27%
By level
- Director28 64%
- Associate & Specialist12 27%
- Senior & Principal2 5%
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Associate Director, Patient Safety Scientist at AstraZeneca
Applications close November 30. $132K–$199K a year, employer provided.