Pharmacovigilance (PV) Systems Operations Manager - GPSE

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Job Description

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.

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