Senior Manager, GPV Collaboration, Integration & Alliance (CIA)
Otsuka Pharmaceutical

Job Info

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Position Summary

The Senior Manager, Global Pharmacovigilance (GPV) Collaboration, Integration & Alliance(CIA) will develop and execute GPV integration strategy, thereby establishing mutual understanding, respect, trust and good communication between GPV affiliate companies and alliances; Responsible to work cross-functionally within Otsuka and with affiliate companies and alliances to ensure effective collaboration to achieve the desired outcomes.

Key Job Responsibilities

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  Collaboration, Integration & Alliances (CIA)
  
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  Support CIA Lead to globalize/harmonize efforts with affiliate companies (i.e. Astex, Visterra) on GPV processes across functional areas and regions through supporting of opportunities for increased collaboration
  
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  Working cross-functionally within Otsuka and with collaborating companies to ensure compliance in all aspects of PV.
  
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  Collaborate and support CIA lead to facilitate discussions on topics identified by colleagues which need creation, improvement and/or harmonization of a process.
  
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  Collaborate with leadership teams and other necessary stakeholders to formulate a strategy for ongoing success in alliances and execute and facilitate that strategy, by establishing mutual understanding, respect, trust, and good communication between GPV, affiliate companies and alliances.
  
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  Manage and direct the PV alliance activities that require consensus by working to gain internal alignment and achieve resolution within the alliance while maintaining positive relationships
  
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  Support CIA lead with Business Continuity Plan (BCP) activities
  
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  Optimizing various pharmacovigilance operational aspects of affiliate companies including Global PV Alliance Management (GPVAM) and Otsuka Alliance Management teams.
  
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  Supports GPV Audit and Inspection Readiness team
  
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  May be assigned to lead or assist with special projects or process development. May perform any other duties as needed.
  

Knowledge, Skills, Competencies, Education, and Experience

Required:

Knowledge:

• Strong knowledge of Otsuka organization and culture
• Experience and working knowledge of clinical operations, the drug development process, regulatory process and commercialization activities
• Extensive knowledge of US, ICH and EU PV and GCP Regulations
• Experience and knowledge to assist teams to prepare for and responding to Health Authority Inspections
• Experience in process improvement initiatives
• Ability to work collaboratively across partnerships
• Experience working with Global teams

Skills:

• 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.
• 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

Competencies:

• Self-starter with proven ability to thrive in a fast-paced team environment handling multiple simultaneous priority tasks
• Ability to adapt to a dynamic work 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.

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.

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