Site Name: Belgium-Wavre
Posted Date: Aug 14 2024

About the role

Work with the SERM (Safety Evaluation and Risk Management) physician to actively manage and evaluate risks associated with assigned vaccine projects, and make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks. This may involve the following:

• Coordinate and perform initial analyses of adverse event reports and/or signal detection activities for assigned vaccine projects in clinical development and post-licensure
• Be the safety contact person for Clinical, Regulatory Affairs, regional and LOC (local operating company) safety managers, manufacturing teams for assigned vaccine projects
• Provide input to Clinical Teams with respect to safety aspects of the design and preparation of protocols, investigators brochures, investigator letters and reports, for the follow up and processing of clinical study data and lead the safety analyses of the assigned projects
• Contribute to the creation, maintenance and implementation of (D)CSI (Development, Core Safety Information) for the assigned projects
• Contribute to the Benefit Risk Assessment and risk identification, assessment and mitigation activities for assigned vaccine projects

About the responsibilities

• Perform database searches to obtain information from the Safety Database
• Assist in the review of aggregated adverse event reports for signal detection, evaluation and management purposes for assigned vaccine projects
• Assist in drafting relevant clinical safety reports (including labelling documents, ad hoc reports and position papers) in collaboration with the safety physician
• Assist in the review of protocols, study reports, IDMC charters, and operational activities associated with appropriate data provision and presentation of material
• Contribute to appropriate and timely Benefit Risk Assessments for assigned vaccine projects
• Contribute to the design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation
• Assist in the review of safety data from other databases (literature review)
• Summarize safety data effectively for use in regulatory or clinical trial documents (e.g. ad-hoc queries, PBRERs, PSURs and DSURs)
• Assist in answering and follow-up of enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects
• Contribute to or even lead the cross-functional Safety Review Team for assigned vaccine project
• Assist in the implementation and follow-up of safety data exchange agreements for products assigned
• Contribute to process improvement and documentation/discussions on procedures; provide support for training to stakeholders
• Generate reliable safety data from large and multinational study environment (200,000 subjects for the ongoing studies)
• Provide scientifically based safety assessments within complex public environment.

About you

• Master degree in a biomedical or health care-related specialty; or bachelor and minimum 5 years of experience
• 2-3 years clinical safety experience or equivalent experience (e.g. clinical development in a pharmaceutical company, regulatory authority etc.)
• Basic understanding of safety evaluation methodology/process awareness of pharmacovigilance regulations and methodologies
• Understanding of medical terminology
• Experience in drafting responses to ad hoc queries or evaluating significant safety issues for regulatory submissions (e.g., PSURs ) under supervision
• High degree of accuracy with attention to detail
• Detail oriented, methodical and analytical approach
• Good communication skills, team spirit, flexibility
• Ability to manage crisis, monitor safety issues and work under pressure with a customer and solution oriented approach
• Able to prioritise activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
• Demonstrate initiative and creativity in performing task and responsibilities. Proactively contributes ideas to improve existing operations
• Good English writing skills
• Computer literate, familiar with using scientific and clinical databases.

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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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