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Featured Employers
Senior Manager Compliance Applications Architect, Global Pharmacovigilance (GPV) Compliance and Business Management (CBM)
Company: Otsuka Pharmaceuticals
Location: Princeton, NJ
Employment Type: Full Time
Date Posted: 12/03/2022
Expire Date: 02/03/2023
Job Categories: Biotechnology and Pharmaceutical
Job Description
Senior Manager Compliance Applications Architect, Global Pharmacovigilance (GPV) Compliance and Business Management (CBM)
Position Summary

The Senior Manager Compliance Applications Architect, Global Pharmacovigilance (GPV) Compliance and Business Management (CBM) will assist in designing and building PV specific solutions which aim to monitor, improve, or optimize Quality and Compliance; Responsible to work cross-functionally within Otsuka to ensure effective collaboration to achieve the desired outcomes. To actively support the GPV Vendor Management activities.

Key Job Responsibilities
Assist the Global Lead of Vendor Management to develop and implement a PV related Vendor Management Process at global, regional and local affiliate level.
Establishing a strong process for notification issues and trends that may affect PV vendors quality and compliance.
Assist in developing continuous monitoring program of vendors throughout the whole life-cycle of the agreement.
Supports monitoring service provider operational delivery (e.g., compliance with SOPs, quality standards, etc.), identifies opportunities for improvement (resource, process, performance) and supports change implementation in partnership with the service provider and internal stakeholders.
Identification of key indicators of vendor' performance.
Works with service providers for resolution of operational issues and questions, identifying training needs and opportunities for improvement, and supporting implementation in collaboration with internal stakeholders.
Attend Global and Regional PV meetings.
Design and develop Solutions or applications to monitor, improve, or optimize PV Quality and Compliance.
Effectively communicate technical strategies to Stakeholders.
Seek out opportunities and processes where optimization can be implemented.
Assist in documentation and training of new solutions.
General SharePoint Maintenance and automation.
May perform any other duties as needed.

Knowledge, Skills, Competencies, Education, and Experience

Experience and working knowledge of clinical operations, the drug development process, regulatory process and commercialization activities
Knowledge of US, ICH and EU PV and GCP Regulations
Experience in process improvement initiatives
Ability to work collaboratively across partnerships
Experience working with Global teams
Good knowledge of PV vendor management

Excellent communication and interpersonal skills.
Strong verbal, writing and organizational skills.
Demonstrate qualities of competency, accountability, and initiative.
Excellent strategic decision-making and analytical skills.
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs.
Advanced problem solving skills.
Advanced SharePoint site maintenance and solution development:
Nintex Workflows
SharePoint list customizations using InfoPath
Word / Excel / VBA /SQL
Strong team working and leadership skills.
Experience managing vendors.
Knows how/when to apply organizational policy or procedures to a variety of situations.
Able to work effectively in a matrix environment.

Education and Related Experience:
Bachelor's degree in education, communication, public health, or other relevant field plus 10+ years of relevant experience in the pharmaceutical industry with administration of training management/LMS administration.
Minimum experience (2-5 years) in clinical, safety, and/or regulatory areas in pharmaceutical industry.
Travel (approximately 10-25%).


Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.


This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Valid Proof of COVID-19 Vaccination or Accommodation

The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
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