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
Knowledge, Skills, Competencies, Education, and ExperienceKnowledge
- 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.
- 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
Education and Related Experience:
- 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.
- 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.Disclaimer:
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
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