Associate, PV Operations Liaison (Global Case Processing)
Otsuka Pharmaceutical

Job Info

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Position Summary

The Associate, PV Operations Global Case Processing Liaison is a global position responsible for assisting in the maintenance of service delivery from PV Operations to any internal Otsuka functional area, department or other Otsuka company (i.e. Clinical Development, Global Regulatory Affairs, PQC). Scope includes but is not limited to interaction within the PV Organization, partners, affiliate, other Otsuka companies and other pharmaceutical companies.

Key Job Responsibilities

PV Operations Strategic Capability Establishment/PV Operations Liaison

• Demonstrate core PV capabilities and assist in the determination and documentation of PV services provided to other departments, PV alliances or other Otsuka companies as needed.
• Maintain relationships with key stakeholders at all levels both internally and externally to the PV Operations organization
• Assist in the delivery and coordination of strategic direction across internal PV functions and other departments as well as external PV alliance partners
• Demonstrate leadership within and outside PV Operations
• Solicit feedback from partners, colleagues and vendors supporting PV activities on policy changes, regulatory changes or business changes that could impact performance and the underlying PV system and communicate that feedback to PV Operations senior management
• Ensures alignment and delivery of PV related activities in accordance and to the extent noted and aligned in the Detailed Description of the Pharmacovigilance System document and Service Level Agreements in the following areas:
  • Case Management (including functionality of the supporting IT systems)
  • Compliance metrics and ICSR quality control
  • Affiliate and local safety manager support where PV Operations is involved in providing PV services
• Serves as liaison between PV Operations and internal functions to identify and surface recommendations for process improvements or new business needs and coordinate implementation of process improvements
• Escalates relevant issues (e.g., non-compliance, etc.) to PV Operations senior management and assist in their resolution
• Ensures that planned PV Operations procedural and/or structural changes are communicated promptly to key stakeholders. Organize and effectively manage direct communications with stakeholders.
• Supports PV Operations in the management of the PV training curriculum assignment process.
• Support internal PV Operation document management
• Perform other tasks as assigned by the management of global PV
• Participate in the development and maintenance of PV System policies, SOP forms, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices

Partner Relationship/Alliance Management Operations

• Represent PV Operations as SME during PV related meetings
• Participate across PV Operations projects to ensure coordination of processes and technology requirements and business need.
• Apply best practices to create and maintain efficiencies in process with regard to partner relationship management
• Assure support is delivered in accordance with agreements including those is PVA's/SLA's.
• Facilitate the development of safety management plans (SMPs) and PVAs
• Assure implementation plans are in place for amended or newly created SMPs and PVA
• Assure compliance with all applicable laws and business processes
• Support Act as subject matter expert for PV Operations during audits and regulatory inspections
• Facilitate issue resolution across functions and partner organizations

Knowledge, Skills, Competencies, Education, and Experience

Required:

Knowledge

• Requires knowledge of standard query language and knowledge of industry terminology.
• Familiarity with drug safety databases
• Strong knowledge of global legislative and regulatory frameworks
• Familiarity with design and function of SMPs and PVAs
• Knowledge and prior experience in case processing
• Knowledge of the interworking's of Global Pharmacovigilance organization is desired
• Experience with managing vendors, partners, and/or CRO's preferred

Skills

• Ability to use software applications to track databases.
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• Excellent command of written and spoken English

Competencies

• Proven ability to work in a team environment and influence decisions with and without authority
• Flexibility to adapt with a fast paced and evolving environment
• Partnership orientation and able to build and sustain strong partner relations
• Customer orientation
• Ability to network across various functional areas within Otsuka
• Problem solving and analytical skills
• Strategic and tactful communication and negotiation skills

Education and Related Experience:

• Bachelor degree in a scientific field, preferably in the health sciences area (e.g., Nursing, Pharmacy)
• Minimum of 2 years of case processing experience in the pharmaceutical industry.

Physical Demands and Work Environment

Travel (approximately 10%)

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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