Senior Safety Scientist

Site Name: Belgium-Wavre, GSK House Posted Date: Jun 22 2022 As Senior Safety Scientist you will work with the Safety 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 Your responsibilities: You are accountable for hands-on understanding of the use of safety databases for adverse event evaluation and reporting. You assist in the review of aggregated adverse event reports for signal detection, evaluation and management purposes for assigned vaccine projects. You assist in drafting relevant clinical safety reports (including labelling documents, ad hoc reports and position papers) in collaboration with the safety physician. You assist in the review of protocols, study reports, IDMC charters, and operational activities associated with appropriate data provision and presentation of material You contribute to appropriate and timely Benefit Risk Assessments for assigned vaccine projects You contribute to the design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation. You assist in the review of safety data from other databases (literature review). You summarize safety data effectively for use in regulatory or clinical trial documents (e.g. ad-hoc queries, PBRERs, PSURs and DSURs). You assist in answering and follow-up of enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects. You contribute to or even lead the cross-functional Safety Review Team for assigned vaccine project. You assist in the implementation and follow-up of safety data exchange agreements for products assigned. You contribute to process improvement and documentation/discussions on procedures; provide support for training to stakeholders. Why you? Basic Qualifications: Degree in a Biomedical sciences or related scientific degree. Minimum 5 years clinical safety experience or equivalent experience ( 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). 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? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *Li-GSK
VaccinesRD 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. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.