Associate Director, Safety Governance

4 tygodni temu

Warszawa, Mazovia, Polska GSK Pełny etat
工作地點名稱: Warsaw, Poznan
刊登日期: May 8 2024

Global position with the objective as part of Safety Governance and GSK Qualified Person for Pharmacovigilance (QPPV) Office, to help ensure GSK QPPV oversight of the Pharmacovigilance Systems and its Quality System.

Safety Governance has accountability for oversight of the global PV system across the entire lifecycle of a product, for GSK portfolio.

Safety Governance is accountable for setting the global oversight strategy to ensure that GSK is compliant with Pharmacovigilance regulations worldwide; thus ensuring that GSK can continue to develop and market products.

The Safety Governance Associate Director plays a key role in supporting the Safety Governance team, and the broader business at both a strategic and operational level. They will also work closely with global stakeholders across all areas of the business to design, deliver and embed new operating models/process changes for their defined areas of responsibility. This will focus on the evolution of the Pharmacovigilance System and its processes in compliance with global legislative requirements.

The position holder works across a matrix environment and across GSK business units, country teams and outsourced provider(s) to ensure appropriate and agreed upon quality standards are met.

The Safety Governance Associate Director role involves refining and communicating the strategy of safety governance, which includes having a detailed perspective of global pharmacovigilance legislation, understanding the impact of that legislation on the global PV Operating Model and having an understanding of pharmacovigilance and drug development, integrating all of that knowledge to make connections with internal and external stakeholders, operationalize and communicate the strategic direction for the QPPV Office and deliver on key priorities. One such priority is the evolution of the Pharmacovigilance System and its processes in compliance with global legislative requirements.


The role is expected to integrate information from these different elements above, to enable synergies and facilitate the evolution of an efficient and effective safety governance and oversight strategy across the global organization

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Develop and maintain good relations with Global Safety, Regional Directors, local operating company safety contacts and stakeholders outside safety as required for coordination of and Strategy for Safety Governance activities
  • Management of relevant documents with responsibility for execution of an effective process to meet legislative requirements in close collaboration with the other QPPV office members.
  • Liaison with cross-functional stakeholders and subject matter experts to coordinate SG activities
  • Maintain an awareness of changes and updates to the global PV system by nurturing a network of contacts and being a highly visible and proactive ambassador. Maintains a good understanding of the global pharmacovigilance system (Central and Local) and the typical interfaces within pharmacovigilance
  • Identify areas for ongoing improvement of the Safety Governance process. Input into strategic discussions to improve the collection and collation of data and implement outcomes to achieve continuous improvement
  • Ensure accurate maintenance and archiving of documentation to support SG activities
  • Plan and execute specific relevant SG projects
  • Develop and share expertise in operational governance tools and methodologies, incl. project and change management, to build capabilities through best practices sharing
  • Provide transversal perspective across projects by maintaining a global view on development program and ensuring liaison and alignment of recommendations/decisions between departmental and/or cross departmental governing bodies/peer reviewed committees.
  • Facilitate departmental and/or cross departmental business/project improvements projects that have a global impact and will deliver significant benefit to Safety Governance
  • Develop and maintain good relations with Global Safety, Regional Directors, local operating company safety contacts and stakeholders outside safety to facilitate the flow of information and ensure action resolution between the QPPV Office and these teams
  • Contribute to ongoing efforts to support the QPPV by providing ideas to improve activities and processes relating to overall safety governance at GSK
  • Provide inspection support as required for both central safety and local inspections (by being able to demonstrate how the SG processes work and to articulate how the QPPV fulfils their role for allocated activities)
  • Provide support, on a as needed basis, for other activities of Safety Governance team
Why you?Basic Qualifications:
  • Master's Degree: (Life sciences related ) Advanced degree preferred
  • Extensive pharmacovigilance experience (10+ years)
  • Knowledge/experience of international pharmacovigilance requirements and drug development and approval processes
  • Experience working in large matrix organizations
  • Proficient in written and spoken English
  • Demonstrated planning and organizational skills
  • Excellent verbal and written communication skills
  • Ability to interact with senior-level stakeholders across multiple functions
Why GSK?

At GSK we offer a wide range of additional benefits:

  • Career at one of the leading global healthcare companies
  • Hybrid work ( 2/3 days per week from the office)
  • Contract of employment
  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
  • Life insurance and pension plan
  • Private medical package with additional preventive healthcare services for employees and their eligible
  • Sports cards (Multisport)
  • Possibilities of development within the role and company's structure
  • Personalized learning approach (internal trainings, mentoring, access to online training' platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
  • Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
  • Supportive community and integration events
  • Modern office with creative rooms, fresh fruits every day

#LI-GSK

#LI-HYBRID

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