New · posted Nov 1
AstraZeneca · Pharmaceuticals
Senior Manager, Safety Scientist
- Boston, MA
- Hybrid
- Full-time
- Manager
The role
Date Posted
22-Sep-2026
Closing Date
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.
What you need
Required skills and experience
- Bachelor’s degree in a biologic/medical/clinical/nursing field with at least 3 years of experience in drug safety/pharmacovigilance
- Knowledge of global pharmacovigilance regulations
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
- Strong scientific writing skills
- Demonstrated learning agility and ability to work independently
- Good judgement
- Ability to interact effectively with people of multiple subject areas and cultures both within and outside the company on a global basis
- Basic understanding of downstream regulatory, patient, business, and reputational impact of PV actions
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Desirable skills
- Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD
- Experience preparing aggregate safety reports and conducting signal surveillance
- Experience with clinical development including risk/benefit analysis and safety assessment
- Expertise with clinical and safety databases
- Experience in MedDRA coding and search strategies
- Strong personal time-management and project-management skills
- Experience with data visualization tools (e.g., Power BI, Spotfire)
- Project leadership, organizational, and prioritization skills
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca's Alexion division, you'll find an environment where innovation thrives. Our commitment to rare diseases means your work will have a profound impact on patients' lives. With a rapidly expanding portfolio and an entrepreneurial spirit, you'll be part of a team that values connection and collaboration. We empower our employees through tailored development programs that align personal growth with our mission. Join us in driving change with integrity while celebrating diversity and innovation.
Ready to make a difference? Apply now to join our team at Alexion!
What you'll do
This is what you will do
The Senior Manager, Safety Scientist plays a pivotal role within Global Patient Safety to actively evaluate and manage safety risks in close collaboration with the GPS Medical Director(s) and cross-functional team members throughout the lifecycle of assigned product(s).
The individual will operate according to the highest ethical, quality and compliance standards as provided by global and local regulations, GxP practice and AZ procedures.
- Contributing to safety data reviews and analyses for products in designated therapeutic areas
- Authoring or reviewing safety sections of clinical documents including but not limited to the clinical study protocol, informed consent form, Investigator’s Brochure, statistical analysis plan, clinical study report, and data monitoring committee documents
- Coordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globally
- Ensuring the oversight of safety for assigned assets, including implementation and execution of the Safety Strategy and Management Team (SSaMT) and Safety Surveillance Team (SST)
- Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis results.
- Authoring and project management of health authority queries
- Maintaining accountability for the authoring, review and finalization (i.e., endorsement, sign-off) of risk management plans and contributing to REMS documents
- Assisting GPS Medical Directors in the development of risk management strategy
- Training and/or leading junior safety scientists and fellows
- Supporting activities related to new drug applications and other regulatory filings including authoring, reviewing and providing input to eCTD modules (2.5 and 2.7.4), core product information (i.e., CCDS), and local labels
- Assisting Global Safety Physicians in developing a strategy for safety-related regulatory activities
- Proactively leading safety documents by driving timely execution, engaging cross-functional stakeholders, and ensuring adherence to safety governance and regulatory timelines Supporting continuous improvement in safety analytics and reporting by contributing to the development of standardized procedures and templates
- Representing global patient safety as a subject matter authority in clinical study teams and cross-functional meetings
- Contributing to initiatives for process improvement and cross-departmental process consistency
- Maintaining a strong, up-to-date solid understanding of evolving global regulations
Pay and benefits
$132,873 – $199,310 a year
Employer provided401(k) retirement plan
Paid vacation and holidays
Paid leaves
Medical, prescription drug, dental and vision coverage
Short-term incentive bonus
Equity-based long-term incentive program
Where you'll work
Boston, MAHybridOpen in Maps (opens in a new tab)
More jobs in Boston, MAEqual opportunity, accessibility and legal noticesAstraZeneca's statements, word for word
The annual base pay for this position ranges from $132,873 to $199,310. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Manager roles in Massachusetts6 roles publishing pay
Manager roles in the US26 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $132,873 | — | $199,310 |
| Massachusetts (middle half) | $154,750 | $169,250 | $175,125 |
| All US (middle half) | $151,000 | $165,750 | $179,875 |
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 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 162 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 40 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- Documentation and SOPs9
- Quality systems and risk4
- GMP and compliance3
- Clinical trial conduct3
- Regulatory submissions2
- Lab testing and methods1
- Investigations and CAPA1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
AstraZeneca on Regulatory Jobs
- 33
- Open roles
- 30
- Distinct roles
- 9
- Locations
By discipline
- Quality15 45%
- Clinical14 42%
- Regulatory4 12%
By level
- Director14 42%
- Associate & Specialist11 33%
- Senior & Principal5 15%
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Senior Manager, Safety Scientist at AstraZeneca
Applications close November 22. $133K–$199K a year, employer provided.