AD PV Affliate Relations Liaison
takeda
Zurich, Switzerland
vor 14 Std.

Job Description

  • Manage the PV relationship with local operating company (LOC) PV personnel within the assigned
  • territory to best support the PV function.

  • Collaborate and liaise with GPSE functions to ensure appropriate systems / processes are in place to support PV locally, regionally and globally
  • Provide Pharmacovigilance functional expertise and support to LOCs
  • In partnership with GPSE functions, leads, facilitates, and executes local, regional and / or global strategies as appropriate.

    ACCOUNTABILITIES :

  • Works across assigned area to support and facilitate LOC PV interactions with other sub-functions
  • of GPSE.

  • Works with Regional Senior Director to implement global, regional and local PV strategies at the LOCs.
  • Maintains appropriate stakeholder network with Commercial, LOCs and R&D to facilitate
  • implementation of GPSE strategy and support the Regional Senior Director to serve as a liaison in their assigned territory to prevent gaps between Commercial and GPSE.

  • To be the SME of their assigned territory as it relates to regulatory requirements, resourcing,
  • compliance and other factors.

  • Supports Affiliate PV Process and Compliance in undertaking impact analysis of PV related
  • regulatory changes, changes to local, regional and global procedures or Takeda policies on local, regional or global PV system.

  • Contribute to and manage assessment of LOC PV training needs and
  • facilitate support for LOC PV training with active involvement / resource

    allocation as needed.

  • Responsible for execution on EU QPPV (and, if appropriate local QPPV) requirements supporting
  • oversight for PV systems in LOCs

  • Maintains Descriptions of Pharmacovigilance Responsibilities (DPRs) with LOC DSOs to provide official record of GPSE and LOC delegation of responsibilities.
  • Work with Cluster Leads, Process and Compliance leads, Vendor Management / Oversight
  • personnel and LOC DSOs in support of LOC PV audits / inspections including follow-up and CAPA

    management.

  • Ensure close collaboration with Process and Compliance leads in ensuring QA and compliance
  • disciplines, globally, regionally and locally to best support LOC needs.

  • Support and advise the Cluster Leads and DSOs on the development / maintenance of PV systems
  • in LOCs and facilitate, as appropriate, local PV SOPs.

  • Works with Regional Senior Director, Cluster Leads, Process and Compliance leads, Vendor
  • Management / Oversight personnel and other stakeholders to facilitate best practice sharing and ongoing process improvement and identification of process efficiencies.

  • Ensures all contact information and any changes of LOC PV personnel are
  • maintained for GPV communications.

  • Support the Vendor Oversight leads with vendor oversight strategy and approach development and execution.
  • EDUCATION, EXPERIENCE AND SKILLS :

  • Health professional (nursing etc) or life science degree
  • Bachelor’s required. Advanced degree preferred.
  • Extensive pharmaceutical or health care related industry experience required
  • Advanced experience in PV related environments, preferably at local, regional and / or global levels.
  • Advanced experience of working cross-functionally
  • Understanding of medical / scientific terminology
  • Excellent knowledge of PV regulations for the post marketing global environment and regional legislation in particular
  • Excellent written / oral communication skills and experience working within virtual teams.
  • Accuracy and attention to detail
  • Flexible mindset
  • High degree of cross-cultural awareness
  • Team worker with collaborative approach.
  • Ability to prioritise under pressure
  • Well-developed organizational skills
  • High standard of computer literacy
  • Job ID R0016593

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