ProClinical is currently recruiting for a Safety Scientist position on behalf of a top 10 global pharmaceutical company. This organization develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally. Based in the company's office in Belgium, this position offers an exciting opportunity to work with an internationally renowned company and bolster a career in the Scientific field.
The Safety Scientist will work with the SERM 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.
- Coordinate and perform initial analyses of adverse event reports and/or signal detection activities for assigned vaccine projects in clinical development and post-licensure.
- Acting as the safety contact person for Clinical, Regulatory Affairs, regional, and LOC (local operating company) safety managers, manufacturing teams for assigned vaccine projects.
- Providing input to Clinical Teams with respect to safety aspects of the design and preparation of protocols, investigators brochures, investigator letters, and reports; following up on and processing of clinical study data and leading the safety analysis of the assigned projects.
- Contributing to the creation, maintenance, and implementation of (D)CSI (Development, Core Safety Information) for the assigned projects.
- Contributing to the Benefit Risk Assessment and risk identification, assessment, and mitigation activities for assigned vaccine projects.
- Performing database searches to obtain information from the Safety Database.
- Reviewing aggregated adverse event reports for signal detection, evaluation, and management purposes for assigned vaccine projects.
- Assisting in drafting relevant clinical safety reports (including labelling documents, ad hoc reports, and position papers) in collaboration with the safety physician.
- Assisting in the review of protocols, study reports, IDMC charters, and operational activities associated with appropriate data provision and presentation of material.
- Contributing to the appropriate and timely Benefit Risk Assessments for assigned vaccine projects.
- Contributing to the design, tracking, and follow up of risk management plans for the products assigned and assure their sound implementation.
- Assisting in the review of safety data from other databases (literature review).
- Summarising safety data effectively for use in regulatory or clinical trial documents (e.g. ad-hoc queries, PBRERs, PSURs and DSURs).
- Assisting in answering and following up on inquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety related aspects.
- Contributing to or even leading the cross-functional Safety Review Team for assigned vaccine project.
- Assisting in the implementation and follow-up of safety data exchange agreements for products assigned.
- Contributing to process improvement and documentation/discussions on procedures; provide support for training to stakeholders.
Skills and Requirements:
- Bachelor level or above degree in a biomedical or health care-related specialty.
- 2-3 years clinical safety experience or equivalent experience (e.g. clinical development in a pharmaceutical company, regulatory authority etc.).
- A 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.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Manon Luflade at +44 2038540586 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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