Associate Director, Global Patient Safety Clinical Operations
Company: Takeda Pharmaceuticals
Location: Baton Rouge
Posted on: May 27, 2023
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Job Description:
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Job Description
About the role:
At Takeda, we are a forward-looking, world-class R&D
organization that unlocks innovation and delivers transformative
therapies to patients. By focusing R&D efforts on four
therapeutic areas and other targeted investments, we push the
boundaries of what is possible in order to bring life-changing
therapies to patients worldwide.
Join Takeda as an Associate Director, Global Patient Safety
Clinical Operations where you will provide functional expertise and
Program level oversight and accountability of PV Activities
globally, including set up and conduct of clinical studies from a
PV perspective. You will also partner with key stakeholders within
and outside PV to ensure continuous harmonized operations of global
Pharmacovigilance activities and maintain highest standards for
integrated functioning. As part of the Global Patient Safety and
Evaluations (GPSE) team, you will report to Director, Global
Patient Safety Clinical Operations.
How you will contribute:
Responsible for overall leadership to support global principles and
standard practices for PV operational activities within clinical
trials.
Identify potential Clinical Development Program issues/risks in a
proactive matter and lead discussions to mitigate them
Perform tasks of daily study specific activities including SAE
reconciliation, study set up, TMF filing
Perform certain key tasks to ensure high data quality and
efficiency
Support study specific Inspection and Audit requests pertaining to
their program
Conduct sample quality review of outsourced activities including
SAE Reconciliation, eTMF filling, SAE Forms and completion
instructions
Review and create Study level documents including Study Management
Plans, Study Safety Summaries and SAE Reconciliation within their
program
Maintain knowledge of PV Regulations and global industry practices
for PV operational efficiency and compliance
Liaise with and advise study teams including Clinical Science, Data
Management, Regulatory Affairs, and other functional areas
locally/globally on matters relating to Pharmacovigilance to ensure
overall compliance and appropriate standards and methodologies
within the company
Ensure consistency in collection, processing to optimize evaluation
of safety data stemming from clinical trials
Represent Pharmacovigilance Operations on Global Program/study
teams
Minimum Requirements/Qualifications:
Bachelor's required. Degree in scientific/medical field or advanced
degree preferred.
8+ years of related experience required.
Demonstrated skills in negotiation and consensus decision
making.
Expert knowledge of clinical trial and Pharmacovigilance
methodologies including detailed comprehension of global regulatory
requirements.
Good cross-cultural understanding and experience.
Critical thinking and analytical skills and ability to make high
level decisions in cross- functional and global environments.
Ability to review, analyze, interpret, and present complex data to
a high standard.
Understanding of and contribution to Takeda business needs and
global strategy.
Able to interact with personnel from all functional areas and
externally to the company at all levels and to represent the
department and company in a highly professional manner.
Good level of computer literacy with Microsoft applications.
Excellent organization skills and ability to prioritize individual
and departmental workloads.
Multi-tasking with the ability to successfully manage multiple
critical issues simultaneously.
Take the initiative to patriciate in projects outside the direct
remit of the job to enhance visibility of the department and ensure
cross functional awareness of GPSE processes and standards.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health
screenings
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs and company match of charitable
contributions
Family Planning Support
Flexible Work Paths
Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development
of novel specialty pharmaceuticals and best in class patient
support programs. Takeda is a patient-focused company that will
inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating
careers, encourages innovation, and strives for excellence in
everything we do. We foster an inclusive, collaborative workplace,
in which our teams are united by an unwavering commitment to
deliver Better Health and a Brighter Future to people around the
world.
This position is currently classified as "remote" in accordance
with Takeda's Hybrid and Remote Work policy.
Base Salary Range: $ 143,000 to $ 205,000, based on candidate
professional experience level. Employees may also be eligible for
Short-term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
Off. This posting is made in compliance with Colorado's Equal Pay
for Equal Work Act, C.R.S. - 8-5-101 et seq
The final salary offered for this position may take into account a
number of factors including, but not limited to, location, skills,
education, and experience.
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
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
#LI-Remote
Keywords: Takeda Pharmaceuticals, Baton Rouge , Associate Director, Global Patient Safety Clinical Operations, Executive , Baton Rouge, Louisiana
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