Director, PV Risk Management

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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. $195,200 - $283,200 per year.

Apply on-line at ~~~ and search for Req #R0123103.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time