Associate Director, Senior Patient Safety Scientist
About this role
Introduction:
The
Associate Director, Senior Patient Safety Scientist
role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist
.
He/she authors and leads PV input to safety documents and regulatory reports.
Associate Director, Senior Patient Safety Scientist
leads meetings and presents safety data and analyses.
Main Responsibilities:
Leads and/or conducts proactive pharmacovigilance and risk management planning for
more complex
products, including preparation of the safety aspects of
G
lobal Risk Management Plans
and
Risk Evaluation and Mitigation Strategies (REMS)
in partnership with the
GSP and others as appropriate
.
Leads
PS
activities
o
f
cross-functional project teams for developmental compounds and/or marketed products.
Leads and provides
safety
expertise
to
I
nvestigator
B
rochures,
P
rotocols,
I
nformed
C
onsents
and
C
linical
S
tudy
R
eports.
Has the ability to
perform duties as a
Safety Strategy and Management
Team (
SSaMT
)
L
eader for larger or more complex projects
.
Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
Leads the collaboration with GSP and Clinical representatives and authors the
Reference Safety Information (RSI)
for multiple or complex development products
.
Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
Authors/provides strategic leadership to regulatory submissions for new products,
formulations
or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
Participates in negotiations and provides
expertise
to
the PS
component
of contracts/agreements with third parties to ensure quality and integrity of agreements.
Trains and
mentors
junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.
Requirements – Education and Experience
A life sciences/pharmacy/nursing degree,
and
demonstrated
Patient Safety and/or Clinical/ Drug Development experience
Fluent in written and verbal English
Advanced knowledge of PV regulations
MD/
MSc/PhD in scientific discipline, preferred
Intermediate understanding of epidemiology, preferred
Date Posted
24-kwi-2026
Closing Date
03-maj-2026
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.