Global Safety Strategist

2 tygodni temu


Gdańsk, Pomerania, Polska LEO Pharma Pełny etat
Role and Responsibilities

The Global Safety Strategist will play a crucial role in assessing, developing, implementing and maintaining solutions supporting the Global Safety strategy in relation to maximize the value of digitalization to ensure faster data driven decision making.

They will facilitate and mature the regulatory partnership with the R&D Outsourcing partner, working closely with the GSLT to give input to the strategy for Veeva Safety Database Support and other systems in GS until decommission.

The ideal candidate will maintain an overview of QMS documents, ensure compliance to pharmacovigilance processes, regulations and guidelines, and ensure and facilitate access to data for end-users to strengthen overview/oversight and driven decisions in Global Safety.

Key Responsibilities
  • Global Safety Business Intelligence & Analytics
    • Lead definition of business requirements/needs for new data reports/visualisations/analytics in collaboration with LoB
    • Develop and maintain data reports/visualisations/analytics in collaboration with LoB
    • Prepare ad hoc data extraction queries and reports on request from LoB
    • Support LoB with functional data analyses as required
    • Identify and initiate process and workflow procedure improvements
    • Drive the change management of the PV systems in impacted departments
  • Drive the Processes in Relation Veeva Updates
    • Assess GS process impact based on R&D and Analytics digest
    • Identify and drive QMS changes as relevant
    • Provide input to R&D Data and Analytics relevant test cases
    • Run User Acceptance Test
    • Coordinate closing windows with R&D Data and Analytics
    • Drive the 3 times/year Veeva upgrades in Veeva in terms of process impact, QMs-related updates and performance of User Acceptance Tests "ever green maintenance
    • Coordinate with relevant GS SMEs
  • Global Safety Systems and Solution Projects and Activities
    • Prepare and deliver project deliverables in accordance with project timelines
    • Coordinate activities as allocated by line manager or project lead
    • Act as SME
    • Facilitate definition of user requirements and specifications in collaboration with LOB
    • Maintain and approve HALO PV until decommission
    • Drive HALO PV upgrades as required until decommission
  • Outsourced Portfolio for Global Safety
    • Support governance of Vendor for all GS tasks
    • Act as the business link between GO and the business liaison
    • Train the trainer in new activities
    • Escalate issues to the business liaison
    • Support the facilitation of issue management from escalated to resolution between GS and the Partner
    • Support the communication of status, issues, decisions and action to relevant stakeholders
    • Support expansion to the operating model with new tasks moved to the outsourced Portfolio, when decided by GS
    • Give input to new activities
    • Not a substitute for the Partner, i.e. solving the tasks/issues for the Partner, but to facilitate and mature the partnership


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