Scientist position focused on safety management and risk assessment. The field of work is pharmaceutical, higher education in this field and experience needed.
As a Safety Scientist SERM, you will work closely with the SERM Safety Physician to actively manage and evaluate risks associated with assigned vaccine projects. You will make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks. Key responsibilities include:
- 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.
- Collaborate with the safety physician to draft relevant clinical safety reports, including labelling documents, ad hoc reports, and position papers.
- Review protocols, study reports, IDMC charters, and operational activities associated with appropriate data provision and presentation.
- 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 assigned products and ensure their sound implementation.
- Review safety data from other databases through 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 following up on inquiries 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 projects.
- Assist in the implementation and follow-up of safety data exchange agreements for products assigned.
- Contribute to process improvement and documentation/discussions on procedures and provide support for training to stakeholders.
- Education: Bachelor's degree or higher in a biomedical or healthcare-related specialty.
- Experience: 2-3 years of clinical safety experience or equivalent (e.g., clinical development in a pharmaceutical company, regulatory authority, etc.).
- Knowledge: Basic understanding of safety evaluation methodology/process and awareness of pharmacovigilance regulations and methodologies.
- Medical Terminology: Familiarity with medical terminology.
- Regulatory Submissions: Experience in drafting responses to ad hoc queries and evaluating significant safety issues for regulatory submissions (e.g., PSURs) under supervision.
- Attention to Detail: High degree of accuracy with attention to detail.
- Communication: Good communication skills, team spirit, and flexibility.
- Crisis Management: Ability to manage crises, monitor safety issues, and work under pressure with a customer and solution-oriented approach.
- Initiative: Demonstrates initiative and creativity in performing tasks and responsibilities, proactively contributing ideas to improve existing operations.
- Language Skills: Good English writing skills.
- Directly employed by Oxford, initial project for half a year, possible: long-term perspective;
- Mobile phone provided & monthly phone contribution;
- Monthly allowance for meal vouchers;
- Travel allowance;
- Hospital & Group insurance;
- Opportunities for education and training;
- Fulltime position, daytime work;
- Region: Brabant
Right to live and work in Belgium