About the role

• Responsible for safety evaluations and risks management of GSK products in the context of product quality incidents and escalations.
• Matrix Leadership across Global Safety and other groups across GSK
• Represents Global Safety at GMP and GVP Regulatory Inspections in the context of Patient Safety and Product Quality.

About the responsibilities

• Skilled at using appropriate internal and external resources to perform safety benefit/risk assessments in relation to product quality incidents and escalations.
• Ability to matrix lead and efficiently collaborate with other key stakeholders across GSK.
• Provide strategy and develop responses to health authority inquiries related to product quality/safety issues.
• Regularly interacts with key stakeholders to maintain the network and discuss related ways of working.
• Trains other functions in the scientific aspects of benefit risk evaluation and preparation of safety/medical assessments and other related safety and regulatory documents.
• Participates in a process improvement initiative. Contributes to advancement of methodology and process by generating new ideas and proposals for implementation.
• Maintains readiness for internal audits and regulatory inspections (GVP, GMP).
• Provides ad-hoc support for other activities in the Transversal Evaluations and Risks Management group

About you

• Master’s degree or higher in Health Sciences or related disciplines
• Five years' experience in Clinical Safety and Pharmacovigilance, specifically focused on Benefit/Risk assessments.
• Fluent in English
• Strong computing skills
• Competent medical/scientific writing skills
• Good knowledge of other relevant disciplines (e.g. statistics, pharmacoepidemiology); knowledge of relevant pharmacovigilance regulations and methodologies
• Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation
• Knowledge of regulations pertaining to Good Vigilance Practices and Good Manufacturing Practices
• Ability to use a range of methods to gather, interpret and analyze data
• Identifies and proposes potential solutions for addressing issues/ problems
• Builds effective working relationships
• Able to manage own tasks and projects and prioritize, with minimal supervision
• Ability to effectively negotiate with stakeholders while being firm and confident on Patient Safety priorities
• Demonstrates effectiveness in oral and written communication.
• Able to meet multiple deadlines successfully and create deliverables of high quality
• Demonstrates initiative taking and creativity
• Able and willing to adjust behaviors and priorities based on changing environment, all aligned with GSK values
• Openness to learning new concepts and applications
• Demonstrates confidence in own ability, integrity and professionalism in interactions with colleagues
• Stays focused under pressure
• Able and willing to train others

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If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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