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Senior Principal Pharmacovigilance Scientist

Company: Takeda Pharmaceutical
Location: Long Beach
Posted on: January 23, 2023

Job Description:

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

  • Job Description Takeda Development Center Americas, Inc. is seeking a Sr. Principal Pharmacovigilance (PV) Scientist with the following requirements: Master's degree in Regulatory Affairs or a related field or foreign equivalent degree plus 2 years of related experience OR Bachelor's degree in Regulatory Affairs or a related field or foreign equivalent degree plus 6 years of pharmacovigilance related experience. Prior experience must include: Conduct safety signal detection, assessment, management from various sources including medical scientific literature and global safety database (2 years); perform medical assessment of individual case and aggregate safety reports for product safety profile and address safety related regulatory authority requests (2 years); apply clinical trial methodology, various regulatory submissions, pharmacovigilance regulations, and safety profile to perform risk/benefit analysis (risk management plan) (2 years); utilize proficient communication skills with ability to review, analyze, interpret and present complex safety data to a high standard during internal and global cross-functional collaborations for patient safety (2 years). Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. Telecommuting allowed from any location in the U.S.

    Apply on-line at and search for Req # R.
    • Additional Job Description Additional 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: Remote

      POSITION : Sr. Principal Pharmacovigilance (PV) Scientist

      POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Sr. Principal Pharmacovigilance (PV) Scientist with the following duties: Apply regulatory and pharmacovigilance knowledge to perform routine/additional PV activities at any stage of product life-cycle as needed; conduct and lead safety monitoring/medical analyses and operational pharmacovigilance activities per the regulatory guidelines; review and provide safety functional support for any regulatory applications/authority requests; represent pharmacovigilance department internally and externally at a global level and to function as an authoritative and professional member of relevant teams; review and provide functional area expertise for clinical study related activities; oversee and collaborate with vendors, cross-therapeutic, and cross-functional colleagues (as needed); provide training/mentoring support as needed.; conduct safety signal detection, assessment, management from various sources including medical scientific literature and global safety database; perform medical assessment of individual case and aggregate safety reports for product safety profile and address safety related regulatory authority requests; apply clinical trial methodology, various regulatory submissions, pharmacovigilance regulations, and safety profile to perform risk/benefit analysis (risk management plan); utilize proficient communication skills with ability to review, analyze, interpret and present complex safety data to a high standard during internal and global cross-functional collaborations for patient safety. Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. Telecommuting allowed from any location in the U.S.

      REQUIREMENTS: Master's degree in Regulatory Affairs or a related field or foreign equivalent degree plus 2 years of related experience OR Bachelor's degree in Regulatory Affairs or a related field or foreign equivalent degree plus 6 years of pharmacovigilance related experience. Prior experience must include: Conduct safety signal detection, assessment, management from various sources including medical scientific literature and global safety database (2 years); perform medical assessment of individual case and aggregate safety reports for product safety profile and address safety related regulatory authority requests (2 years); apply clinical trial methodology, various regulatory submissions, pharmacovigilance regulations, and safety profile to perform risk/benefit analysis (risk management plan) (2 years); utilize proficient communication skills with ability to review, analyze, interpret and present complex safety data to a high standard during internal and global cross-functional collaborations for patient safety (2 years). Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. Telecommuting allowed from any location in the U.S.

      Full time. $130,200.00 to $251,100.00 per year. Competitive compensation and benefits.

      Qualified applicants can apply at Takeda careers page at: . Please reference job . 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.

      EEO Statement

      Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

      Locations

      California - Virtual

      Worker Type

      Employee
      Worker Sub-Type

      Regular
      Time Type

      Full time

Keywords: Takeda Pharmaceutical, Long Beach , Senior Principal Pharmacovigilance Scientist, Other , Long Beach, California

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