Senior Manager, PV Operational Excellence
Lexington, Massachusetts- Job Type: Full Time
- Job Level: Senior
- Travel: Minimal (if any)
Within Takeda’s Data Sciences Institute, we harness the insight of data and digital to speed the development of new medicines to patients. The Data Sciences Institute (DSI) is primarily focused on getting medicines to patients faster through innovation and efficiencies driven by data and analytics.
We nurture a culture that encourages disciplined risk-taking, supports innovation, values diversity and emphasizes implementation.
We want to hire and develop the best talent to join us on our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine!
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Job Description
Takeda Development Center Americas, Inc. is seeking a Senior Manager, PV Operational Excellence in Lexington, MA with the following requirements: Bachelor’s degree in Pharmacy or related field plus 6 years of related experience. Prior experience must include: Investigate quality deliverables through Track wise systems; Design, implement, and manage the records retention services for pharmacovigilance files at Iron Mountain, overseeing the secure storage, organization, and compliance with regulatory standards throughout the entire lifecycle of the documents; Generate and analyze reports within the Oracle Siebel CTMS, Medidata CTMS, and EDC Rave, Veeva Systems, CTMS, to provide insights into study site performance and potential issues; Analyze regional guidelines and requirements beyond FDA and EMA, such as those from the ASEAN countries or Latin America, Health Canada, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and the Therapeutic Goods Administration (TGA) in Australia; Analyze, configure, generate safety reports, and meet regulatory requirements through Oracle Argus Safety, ArisG and Safety Easy platform including MedDRA and WHO Drug; Prepare and teste electronic submission gateways for Health authority submissions and secure file transfer pathways for gateways execution; Determine vascular occlusive events and analyze PBRER,DUSR listing QC under Oncology therapeutic area. Up to 30% domestic or international travel required. 100% telecommuting allowed from anywhere in the U.S.
Full time. $175,115 - $228,000 per year.
Apply on-line at https://jobs.takeda.com and search for Req #R0131351.
Locations
Lexington, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWhere you fit in
When you join our Data Sciences Institute team, you’ll connect with a diverse and talented group of scientists, engineers and analysts. Together, you’ll define cutting-edge algorithms, conduct pharmacology-based modeling and explore new approaches to data services. In a collaborative environment marked by strong, open and honest leadership, you’ll take charge of your professional advancement as you work on important projects that grow your skills and lead to ongoing opportunities.
A career within the Data Sciences Institute at Takeda will give you everything you need to succeed professionally. You’ll see up close that what you do with information and insight has the power to impact the lives of patients — today and for generations to come. Working here, you’ll understand that our people-first perspective extends beyond patients to include our Takeda team, our families and the communities where we all work and live.
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Work with various data sources
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Apply a breadth of methodologies
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Develop analysis pipelines
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Design studies
We’re using the newest technology and methods, like wearable devices and machine learning, to better understand the health of patients participating in our trials.
Ariel Dowling - Head, Sensing & Measurement, Digital Health Sciences
The energy, professionalism and commitment that I experienced in every encounter, starting from the interview process, to meeting with the hiring manager, through to receiving an offer, left me feeling a certain level of consistency and thoughtfulness. That made me really feel enthusiastic.
Brian Johnson - Head, R&D Technology, Data Sciences Institute
Being able to predictably deliver on our portfolio priorities is where we have laser-focus each and every day. By doing this, we keep our eye on the prize of bringing new medicines to patients, and show the value that these treatments can bring to their lives.
Simon Davies - Head of R&D Data & Quantitative Sciences
How you'll shine
Many talents one goal
Our pipeline
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.
What we believe in
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.
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Integrity
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Fairness
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Honesty
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Perseverance
Working at Takeda
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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.
We're Steadfast In Our Commitment to Four Key Imperatives
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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