Safety, Evaluation and Risk Management, Principal Scientist

Job content

Site Name: Belgium-Wavre, GSK House

Posted Date: Dec 16 2022

As Safety, Evaluation and Risk Management (SERM) Principal Scientist, you will work with the SERM 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, and manufacturing teams for assigned vaccine projects
• Provide input to Clinical Teams concerning 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
  
  

Key responsiblilities:

• 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.
  
  

Why you?

• Degree in a Biomedical sciences or Healthcare elated degree.
• Previous experience in clinical safety or equivalent ( e.g. clinical development in a pharmaceutical company, regulatory authority, etc.)
• Understanding of safety evaluation methodology/ process awareness of pharmacovigilance regulations and methodologies.
• Understanding of medical terminology and Medical Dictionaries (e.g., MedDRA).
• Hands-on understanding of the use of safety databases for adverse event evaluation and reporting.
• Experience drafting responses to ad hoc queries or evaluating significant safety issues for regulatory submissions (e.g., PSURs ) under supervision.
• Detail-oriented, methodical and analytical approach.
• Good communication skills, team spirit, flexibility.
• Leadership skills appropriate for dealing with a small-medium multidisciplinary team
• 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 tasks and responsibilities. Proactively contributes ideas to improve existing operations.
• Good English writing skills.
• Computer literate, familiar with using scientific and clinical databases.
  
  

Why GSK?

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

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.

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re 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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