Director, Principal Patient Safety Scientist
Company: AstraZeneca
Location: Montgomery Village
Posted on: February 20, 2026
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Job Description:
At AstraZeneca, we put patients first and strive to meet their
unmet needs worldwide. Working here means being entrepreneurial,
thinking big and working together to make the impossible a reality.
If you are swift to action, confident to lead, willing to
collaborate, and curious about what science can do, then you’re our
kind of person. Recognizing the importance of individualized
flexibility, our ways of working allow employees to balance
personal and work commitments while ensuring we continue to create
a strong culture of collaboration and teamwork by engaging
face-to-face in our offices 3 days a week. Our head office is
purposely designed with collaboration in mind, providing space
where teams can come together to strategize, brainstorm and connect
on key projects. Our dedication to sustainability is also central
to our culture and part of what makes AstraZeneca a great place to
work. We know the health of people, the planet and our business are
interconnected which is why we’re taking ambitious action to tackle
some of the biggest challenges of our time, from climate change to
access to healthcare and disease prevention. The Director,
Principal Patient Safety Scientist role provides expertise to
multiple and/or single but sophisticated products in different
stages of development as needed. They provide oversight of safety
documents and deliverables for these projects in collaboration with
the Global Safety Physician (GSP) and other PV Scientists. They
lead PV strategy for safety documents and regulatory reports. Main
Responsibilities: Leads the strategy for proactive
pharmacovigilance and risk management planning of complex or
multiple products, including preparation of the safety aspects of
Global Risk Management Plans and Risk Evaluation and Mitigation
Strategies (REMS) in partnership with the GSP and others as
appropriate. Provides subject matter expertise in the therapeutic
area and across multiple products. Has the ability to lead
cross-functional process improvement or other initiatives on behalf
of the Patient Safety organization. Performs duties as a Safety
Strategy and Management Team (SSaMT) Leader for complex and/or
multiple products. As a Safety expert leads presentation of complex
issues to Safety Information Review Committee (SIRC). Leads safety
strategy for multiple or complex periodic regulatory documents
(PBRERs, PSURs, DSURs) according to the agreed process and
timelines. Leads safety strategy for regulatory submissions of new
products, formulations or indications (NDA/BLA, MAA), in
partnership with the GSP and other functional experts. Leads
negotiations and provides expertise to the PS component of
contracts/agreements with third parties to ensure quality and
integrity of agreements. Takes accountability and leads resolution
of complex safety issues and mediates cross-functional agreement.
Has the ability to participate in due diligence activities. As a
safety expert, provides training and mentorship to new GSPs and PV
Scientists in approved processes and systems. Requirements –
Education and Experience Minimum 8 years of experience. Minimum
Life sciences/Pharmacy/Nursing degree, and advanced Patient Safety
and/or Clinical/ Drug Development experience MD/MSc/PhD in
scientific field, preferred Advanced knowledge of PV regulations
Advanced understanding of epidemiology, preferred Our positions
offer eligibility for various 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.
Keywords: AstraZeneca, Germantown , Director, Principal Patient Safety Scientist, Science, Research & Development , Montgomery Village, Maryland
