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Takeda Pharmaceutical Company Limited
Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.
In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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, Signal Management Process Excellence in Cambridge, MA, where you will oversee the signal management processes to ensure that signal management activities are performed according to regulatory requirements. You will monitor and document signal-management related Key Performance Indicators (KPIs) and metrics and support requests regarding information related to signal management KPIs.This role will conduct review of signal management processes to identify areas for continuous improvement along with develop and implement process excellence strategies to enhance the efficiency and quality of signal management activities.
As part of the Signal Management and Innovation (SMI) team, you will report to the Senior Director, Head, Signal Management and Innovation (SMI). You will review and support updates to signal management controlled documents and training materials to stay up to date with process updates, updated regulatory requirements, and process improvements associated with signal management processes. You will collaborate with cross-functional teams e.g., PSPV Training, PSPV Risk Management & Education, and Document Learning Excellence (DLE) to develop resources and training materials for interactive live and online trainings on signal management processes and intersections with supporting functions, and safety and signal management related topics. Lastly, you will participate in inspection readiness activities, including review of archived documentation in support of Signal Management processes, and as a signal detection and management subject matter expert (SME) during audits and inspections.
Act as an interface between the Signal Management, Medical Safety, as well as vendor companies on matters of Signal Management to identify areas of opportunities for process enhancements and efficiencies.
Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal PSPV stakeholders.
Keep up to date with applicable regulations and ICH/GCP guidelines to ensure proper benefit-risk assessment and patient safety for company’s products.
Represent all activities related to pharmacovigilance, clinical safety, risk management and signal detection, and report relevant information regarding status, issues, and/or challenges.
Participate in training sessions, workshops, and/or conferences, and share knowledge with team members, as agreed.
Conduct project activities for designated processes.
Any other tasks assigned by manager to assist in related departmental activities.
Health care background or life science degree/Bachelors required; degree in life sciences preferred
Experience in the pharmaceutical industry with at least 10 years of relevant experience in pharmacovigilance
In depth knowledge and experience of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysis
Critical, strategic thinking and decision-making skills
Ability to review, analyze, interpret and present complex data to a high standard
Global player in a PV organization with the ability to adapt to change
Ability to work collaboratively in a cross-functional, global environment
Excellent document creation, communication, and presentation skills
Good level of computer literacy
Excellent organization and project management skills with ability to prioritize
Proven track record in process improvement and implementing process excellence initiatives
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” by Takeda’s Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - VirtualU.S. Base Salary Range:
149,100.00 - 234,300.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
Job Exempt
Yes#LI-Remote
During my 20-year journey here, I’ve been fully supported by my colleagues, and I can’t say enough about our rich internal talent and the long-standing values that drive our decisions as we work to develop important medicines for the patients we serve.
Doug Coffman - Head, R&D Asset Transition & Integration Office, R&D Regional & Business Operations
When making any type of decision, the first thing we ask is 'how will this impact patients?’ Ultimately, we’re laser focused on the best interests of the patient, and I truly believe we follow through on that.
Meredith Culp - VP, Head of Neuroscience Therapeutic Area Strategy & Operations and Head of Global Development Integration Office
Our culture and shared values make us like a family here at Takeda. It doesn't feel like work when you're doing something you love with people you love, and when your outcome is really fantastic.
Alison Handley, Head, Center for External Innovation
The heart of our work
Shining a light on new perspectives
Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.
Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.
We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.
Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.
Integrity
Fairness
Honesty
Perseverance
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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