Job Description

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 strategy in relation to PV system oversight in order to ensure that GSK is compliant with Pharmacovigilance regulations worldwide; thus ensuring that GSK can continue to develop and market products.

This role supports the Senior Vice President; Head of Clinical Safety and Pharmacovigilance by ensuring that defined activities to support delivery of the Safety Governance strategic objectives are fully met.

The Safety Governance 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 individual department line heads, and 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 Director role involves refining and communicating the strategy of safety governance, which includes having a detailed and strategic perspective of global pharmacovigilance legislation, understanding the impact of that legislation on the global PV Operating Model and having a deep 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 also supports the objectives of the Senior Vice President; Head of Clinical Safety and Pharmacovigilance in demonstrating increased compliance and reducing critical audit findings. This role will play a key part in strategy for supporting central and LOC audit and inspection activities.

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 with a particular focus on regulations implementation and process development.

Key Responsibilities

• Coordinate with appropriate quality assurance teams and inspection teams for audits of QPPV and PSMF services and procedures. Coordinate CAPAs, etc. that arise from audits and inspections for area of expertise to support consistent approach across diverse regions.
• Establish robust training curriculum\xe2\x80\x93 ensure GSK supplied training material remains current and conduct regular reviews of training program in relation to QPPV and PSMF activities globally.
• Develop and coordinate rollout of approved process improvement initiatives across regions including 3rd parties
• Lead the refinement and implementation of the strategy, development and effectiveness of the safety governance group. This is a role that involves establishing relationships with important stakeholder and customer groups across various internal functions (e.g. PVQA, Compliance Boards, LOC network, Regulatory, Manufacturing) and maintaining a healthy external network for benchmarking, legislation awareness and sharing of best practice.
• Generate and maintain a consistent, stable and robust environment for carrying out governance and oversight activities of regulations implementation and process development whilst maintaining a consistent GSK wide approach
• Support the Senior Vice President; Head of Clinical Safety and Pharmacovigilance, QPPV and the delegates in the attainment of short, medium and long-term goals.
• Develop and maintain partnerships with key colleagues in GSK functional areas ensuring ongoing alignment of goals and strategies. They will also develop and maintain partnerships with key external groups, such as Regulators, other pharma and trades associations to optimally deliver against goals and strategies.
• This role will work with the Safety Leadership Team and the Global Medical Leadership Team to maintain awareness of QPPV Office operational objectives and best practices. They will write (Input to the compilation of) briefing and communications materials, as needed and will manage information technology resources appropriate to the role to meet current and future business goals.
• Enterprise-wide thinking is key in this position, since the QPPV oversees the PV system for the GSK portfolio. The role will integrate information gained from all aspects of the position in order to support Global Safety in implementing and overseeing a streamlined suite of processes which enable compliant ways of working.

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GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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