Senior Principal Pharmacovigilance Scientist
Company: Takeda Pharmaceutical
Location: Long Beach
Posted on: January 23, 2023
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Job Description:
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Job Description
Apply on-line at and search for Req # R.
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that
an application for Alien Employment Certification will be filed by
Takeda Development Center Americas, Inc. for the following job
opportunity:
JOB LOCATION: Remote
POSITION : Sr. Principal Pharmacovigilance (PV) Scientist
POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is
seeking a Sr. Principal Pharmacovigilance (PV) Scientist with the
following duties: Apply regulatory and pharmacovigilance knowledge
to perform routine/additional PV activities at any stage of product
life-cycle as needed; conduct and lead safety monitoring/medical
analyses and operational pharmacovigilance activities per the
regulatory guidelines; review and provide safety functional support
for any regulatory applications/authority requests; represent
pharmacovigilance department internally and externally at a global
level and to function as an authoritative and professional member
of relevant teams; review and provide functional area expertise for
clinical study related activities; oversee and collaborate with
vendors, cross-therapeutic, and cross-functional colleagues (as
needed); provide training/mentoring support as needed.; conduct
safety signal detection, assessment, management from various
sources including medical scientific literature and global safety
database; perform medical assessment of individual case and
aggregate safety reports for product safety profile and address
safety related regulatory authority requests; apply clinical trial
methodology, various regulatory submissions, pharmacovigilance
regulations, and safety profile to perform risk/benefit analysis
(risk management plan); utilize proficient communication skills
with ability to review, analyze, interpret and present complex
safety data to a high standard during internal and global
cross-functional collaborations for patient safety. Company
headquarters in Lexington, MA. Individual may reside anywhere in
the U.S. Telecommuting allowed from any location in the U.S.
REQUIREMENTS: Master's degree in Regulatory Affairs or a related
field or foreign equivalent degree plus 2 years of related
experience OR Bachelor's degree in Regulatory Affairs or a related
field or foreign equivalent degree plus 6 years of
pharmacovigilance related experience. Prior experience must
include: Conduct safety signal detection, assessment, management
from various sources including medical scientific literature and
global safety database (2 years); perform medical assessment of
individual case and aggregate safety reports for product safety
profile and address safety related regulatory authority requests (2
years); apply clinical trial methodology, various regulatory
submissions, pharmacovigilance regulations, and safety profile to
perform risk/benefit analysis (risk management plan) (2 years);
utilize proficient communication skills with ability to review,
analyze, interpret and present complex safety data to a high
standard during internal and global cross-functional collaborations
for patient safety (2 years). Company headquarters in Lexington,
MA. Individual may reside anywhere in the U.S. Telecommuting
allowed from any location in the U.S.
Full time. $130,200.00 to $251,100.00 per year. Competitive
compensation and benefits.
Qualified applicants can apply at Takeda careers page at: . Please
reference job . EOE
Any individual may provide documentary evidence bearing on this
application, with information on available workers and information
on wages and working conditions, to the Certifying Officer, U.S.
Department of Labor, Employment and Training Administration, Office
of Foreign Labor Certification, 200 Constitution Avenue, NW, Room
N-5311, Washington, DC 20210.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce
and providing equal employment opportunities to all employees and
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, gender expression,
parental status, national origin, age, disability, citizenship
status, genetic information or characteristics, marital status,
status as a Vietnam era veteran, special disabled veteran, or other
protected veteran in accordance with applicable federal, state and
local laws, and any other characteristic protected by law.
Locations
California - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Long Beach , Senior Principal Pharmacovigilance Scientist, Other , Long Beach, California
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