Powered by
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.
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: Cambridge, MA
POSITION: Pharmacovigilance (PV) Systems Operations Manager - GPSE
POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Pharmacovigilance (PV) Systems Operations Manager - GPSE with the following duties: Review and execute pharmacovigilance agreements/contracts between Takeda and partners; vendor management and oversight for expedited reporting, incoming and outgoing ICSR; perform Argus Safety database configuration and change control procedures; perform testing of new system functionality liaison with PV compliance team and coordinate/investigate submission compliance; liaise with IT team to resolve issues with Argus safety; liaise with PV Operations team to assess and prioritize daily tasks; prepare relevant work instructions/job aids relevant to daily operations and train vendors; identify and appropriate escalation of issues within team or department to manager; represent pharmacovigilance department internally and external, in an effective and professional manner. Assess system changes during MedDRA update; Generate/review aggregate listings for Health Authority inspections and audits; develop and conduct training for users.
REQUIREMENTS: Bachelor’s degree in a medical, scientific, or related field or foreign academic equivalent plus 6 years of related experience. Prior experience must include: Process individual case safety reports for drugs and medical devices from clinical trial, spontaneous and published reports and perform quality control activities; submit expedited reports to regulatory authorities and business partners and conduct validation testing of data migrations and safety upgrades; coordinate expedited reporting requirements and processes for global ICSR reporting and distribution to regulatory authorities, LOCs, alliance partners, CROs and ethics committees; update global safety database configuration, including product license configuration, license partner and regulatory agency reporting rule set-up, and study record creation. Up to 5% travel required. Up to 100% remote work allowed.
Full time. $133,000.00 - $228,000.00 per year. Competitive compensation and benefits.
Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0137977. 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.
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.
Get customized job alerts sent right to your inbox. Plus, get the latest in company news and other important resources by signing up for our talent community.
