About the role
1. Responsible for safety evaluations and risks management of GSK products in the context of product quality incidents and escalations.
2. Matrix Leadership across Global Safety and other groups across GSK
3. Represents Global Safety at GMP and GVP Regulatory Inspections in the context of Patient Safety and Product Quality.
About the responsibilities
4. Skilled at using appropriate internal and external resources to perform safety benefit/risk assessments in relation to product quality incidents and escalations.
5. Ability to matrix lead and efficiently collaborate with other key stakeholders across GSK.
6. Provide strategy and develop responses to health authority inquiries related to product quality/safety issues.
7. Regularly interacts with key stakeholders to maintain the network and discuss related ways of working.
8. Trains other functions in the scientific aspects of benefit risk evaluation and preparation of safety/medical assessments and other related safety and regulatory documents.
9. Participates in a process improvement initiative. Contributes to advancement of methodology and process by generating new ideas and proposals for implementation.
10. Maintains readiness for internal audits and regulatory inspections (GVP, GMP).
11. Provides ad-hoc support for other activities in the Transversal Evaluations and Risks Management group
About you
12. Master’s degree or higher in Health Sciences or related disciplines
13. Five years' experience in Clinical Safety and Pharmacovigilance, specifically focused on Benefit/Risk assessments.
14. Fluent in English
15. Strong computing skills
16. Competent medical/scientific writing skills
17. Good knowledge of other relevant disciplines (e.g. statistics, pharmacoepidemiology); knowledge of relevant pharmacovigilance regulations and methodologies
18. Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation
19. Knowledge of regulations pertaining to Good Vigilance Practices and Good Manufacturing Practices
20. Ability to use a range of methods to gather, interpret and analyze data
21. Identifies and proposes potential solutions for addressing issues/ problems
22. Builds effective working relationships
23. Able to manage own tasks and projects and prioritize, with minimal supervision
24. Ability to effectively negotiate with stakeholders while being firm and confident on Patient Safety priorities
25. Demonstrates effectiveness in oral and written communication.
26. Able to meet multiple deadlines successfully and create deliverables of high quality
27. Demonstrates initiative taking and creativity
28. Able and willing to adjust behaviors and priorities based on changing environment, all aligned with GSK values
29. Openness to learning new concepts and applications
30. Demonstrates confidence in own ability, integrity and professionalism in interactions with colleagues
31. Stays focused under pressure
32. 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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