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Takeda Development Center Americas, Inc
Cambridge
Takeda Development Center Americas, Inc. is seeking a Director, PV Risk Management in Cambridge, MA to provide global strategic leadership and expertise in risk management across therapeutic areas. Up to 5% travel required. Up to 100% remote work allowed from anywhere in the US. Full tim...
Job Source: Takeda Development Center Americas, IncTakeda
Boston, MA, United States
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 r
Job Source: TakedaTakeda Pharmaceuticals
Boston, MA, United States
Takeda Pharmaceuticals Director, PV Risk Management Boston , Massachusetts Apply Now 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’s Privacy Notice and Terms of Use . I further at
Job Source: Takeda PharmaceuticalsONO PHARMA USA
Cambridge, MA, United States
To promote proper use by conducting necessary internal and external communication such as consultation with the domestic regulatory authority so that safety measures planned based on the risk/benefit evaluation of each product can be appropriately implemented based on the developed PV plan. To develop human resources for appropriate business operat
Job Source: ONO PHARMA USAONO PHARMA USA
Cambridge, MA, United States
To promote proper use by conducting necessary internal and external communication such as consultation with the domestic regulatory authority so that safety measures planned based on the risk/benefit evaluation of each product can be appropriately implemented based on the developed PV plan. To develop human resources for appropriate business operat
Job Source: ONO PHARMA USAManulife
Boston
We are a leading financial services provider committed to making decisions easier and lives better for our customers and colleagues around the world. From our environmental initiatives to our community investments, we lead with values throughout our business. To help us stand out, we help you step up, because when colleagues are healthy, respected
Job Source: ManulifeBright Horizons
Newton
This role will support the implementation and success of Bright Horizons’s technology strategy by ensuring we are making strategic investments in the right areas. Leveraging business acumen, a deep understanding of Bright Horizons’s business, and effectively partnering across different levels of the organization, this role will implement demand gov
Job Source: Bright HorizonsGoTo
Boston
**Job Description** **Where you’ll work:** remote US (EST or CST time zone) **Where you’ll work:** remote US (EST or CST time zone) **Product at GoTo** At GoTo, we’re passionate about building powerful, flexible-work software that empowers individuals to thrive professionally and personally. We’re also dedicated to fostering a diverse and inclusive
Job Source: GoToBoston
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’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
Takeda Development Center Americas, Inc. is seeking a Director, PV Risk Management in Cambridge, MA with the following requirements: Master’s degree in Regulatory Affairs, Pharmaceutical Sciences, Public Health, or life sciences or related field or foreign academic equivalent plus 8 years related experience. Prior experience must include: Strategize, author, and review Global and European Risk Management Plans (RMP) Core-RMP, EU-RMP other RMP including those for first or supplementary marketing authorizations applications (NDA submissions); Advise product team on the maintenance and implementation of REMS program for assigned product and support FDA response requests; Support health authority inspections and audits (on behalf of the company) for assigned products including supporting FDA Inspections and MHRA (The Medicines and Healthcare products Regulatory Agency) inspections; Engage in cross-functional strategic discussions for management of activities including planning, authoring and review of periodic aggregate reports like Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER/PAER) in compliance with global regulations. Up to 5% travel required. Up to 100% remote work allowed from anywhere in the US.
Full time. $196,000 - $283,200 per year.
Apply on-line at akeda.com and search for Req #R0123103.
**Locations**
Boston, MA
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
Email Alert for Director, PV Risk Management_ jobs in Boston
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