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