Senior Manager, Global Pharmacovigilance Scientist

Profile

Senior Manager,Global P
harmacovigilance Scientist
Reports to:
Director,
Global Safety Study Management
Location:
Cheshire, CT
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes
Soliris
eculizumab
), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (
aHUS
), two life-threatening ultra-rare disorders. Alexion is also establishing a premier global metabolic rare disease franchise, which includes Kanuma™ (
sebelipase
alfa
) for patients with lysosomal acid lipase deficiency (LAL-D), and
Strensiq
asfotase
alfa
) for patients with
hypophosphatasia
(HPP). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas. As the global leader in complement inhibition, the Company is strengthening and broadening its portfolio of complement inhibitors across diverse platforms, including evaluating potential indications for
Soliris
in additional severe and ultra-rare disorders. Further information about Alexion can be found at: ****Position Summary
This position is responsible for the execution of the deliverables for the G
lobal Pharmacovigilance (GPV)
Safety Study Management Team.
The
G
PV
Scientist
plays a pivotal role within Global Pharmacovigilance to
ensure
safety
assessment
for all
Alexion products. This person will provide
scientific
and
compliance
expertise as needed to GPV
according to Alexion PV SOPs and standards
and will be a key member of core study team representing GPV Operations
Principal Responsibilities
Responsibilities for this role include, but are not limited to:
Serve as a member of Global development and post approval core team
’s subcommittee & teams
Collaborate
s
with other Alexion departments and vendors to ensure data collection, analysis
and reporting
in Alexion interventional
non-interventional
trials
and IIT/ISR
is in compliance with global regulatory
requirements
and Alexion SOPs
Serve
s
as a
n
expert on
pharmacovigilance
global regulations
guidelines and industry best practices
Ensure
s
compliance
with
health
authority
regulations
with regards to data collection
, analysis, reporting standards and operational consistency across interventional
and non-interventional trials
Performs initial analysis and writing of the safety section of Alexion’s protocols and other safety related documents
in collaboration with RML’s
Collaborate
s
with Clinical Operations
, Data
M
anagement, Clinical CRO
and Study Teams in development of
the
safety related data collection forms, table design, and listings for safety data from interventional
non-interventional trials
Review
s
and
provide
s
input and support with other departments (e.g.,
clinical operations,
medical information, regulatory affairs,
medical affairs,
commercial CRO
and
data management)
groups
on
safety/
PV
related
topics for study protocols, statistical analysis plans and other clinical related documents
Write
s
the safety section in c
ollaboration
with team members on
regulatory
responses,
IBs
/CCDS
study
protocols,
CRFs,
Data Monitoring Committees reports and request
s
and
other
documents
, and provide
the necessary quality control
Work
s
directly with and s
upport
s
the PV
safety physician
s
(RMLs)
in data collection and assessment needs for SMTs, CSRs, GSC,
PBER, DSUR and
a
d
hoc requests
etc.
Ensure
s
compliance and quality are maintained and issues are escalated
appropriately
and resolved
Author
s
Safety Assessment Reports and other safety documents (e.g., regulatory request, Data Monitoring Committees, IBs and C
RFs) in collaboration with the G
lobal Safety Physicians
Runs/supports routine signal detection processes in partnership with RML for
assigned
products
and
and
write
s
up
the
analysis results
Works with RML to prepare agenda, presentations and minutes for Safety Management Team meetings.
P
repare
s
presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making bod
ies
Supports
Safety Physicians
or RMLs
in the development of risk managem
ent strategy and activities:
Provides conte
nt
for
safety aspects of
risk management plans
Assists the RML with project management of the safety aspects of global risk management plans
Develop
s
or update
s
strategy and content for regional risk manag
ement plans
Assist
s
Safety Physicians
to oversee risk minimization activities including trac
king of activities as needed
Assist
s
in the evaluation
of
risk minimization activity
Assist with
response
s
to regulatory inquiries related to risk management plans under the guidance of
global safety
physicians
Support
s
activities related to new drug applications
and other regulatory filings
Assist
s
G
lobal Safety Physicians
in developing a strategy for safety-
related regulatory activities
Provide
s
safety contents for filings
Assist
s
with the execution of CAPAS to minimize compliance gaps with the remit of role and responsibility
Performs other duties related to the position as ne
cessary as defined in SOPS and/
or as request by Supervisor
Serve as a SME for pre and post approval inspection
f
or the studies
/products under
their responsibility
Qualifications
Demonstrated
proficiency in global regu
latory requirements, guidelines
and industry best practices for pharmacovigilance with experience in safety related organized data collection, analysis and reporting (e.g., interventional and
non-interventional clinical trials
, registries, patient programs, mark
et research programs
Expertise with PV
clinical and
safety database
s
e.g., structure and conventions)
Experience in MedDRA coding and search
strategies
Strong people and project leadership skills
Strong organizational and prioritization skill
Excellent analytical and problem solving sills
Excellent
communication skills
oral and written
, including medical / scientific writing
Experience in safety data analysis and writing study related aggregate reports and safety assessments
Literature search, evaluation and assessment skills
Presentation skills for conveying complex technical contents to non-expert audience
Demonstrated commitment to q
uality and compliance
Demonstrated learning agility
and ability to work
independently, seeking
advice as required
Ability
to interact effectively with
people
of multiple disciplines and cultures both within and outside the company on a global basis
Expert
ise with
Micros
oft Word, PowerPoint
SharePoint and
Excel
Understanding of clinical development processes related to clinical trials preferred
Education
Minimum:
Pharmacist/PharmD
or BS/Masters in Nursing
with a minimum of 3 years
of
clinical
experience
Minimum
8
years of
related experience
supporting PV in a pharmaceutical environment required
Preferred
BS Nursing, Master’s
Degree
or
RPh
PharmD
Competencies
Organizing
Informing
Decision Quality
Problem solving
Drive for Results
Managing and measuring work
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and thei
r families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
To learn more about Alexion, please visit
****or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /
Affirmative action employer
*LI-MW1

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