Senior Manager, PV Operational Excellence

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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, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time