Hobson Prior are seeking an experienced Safety Scientist to join a highly established, pharmaceutical company that research and produce pharmaceutical medicines, vaccinations and other healthcare products.
- Assist the SERM Safety Physician to manage risks associated with vaccine projects and make suggestions for the management and communication of risks in accordance with global legal and regulatory frameworks.
- Analyse adverse event reports and/or signal detection activities for assigned vaccine projects in clinical development and post-licensure.
- Act as the safety contact person for Clinical, Regulatory Affairs, regional and Local Operating Company safety managers, manufacturing teams for assigned vaccine projects.
- Provide input 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 analysis of the assigned projects.
- Contribute to the creation, maintenance and implementation of (D)CSI for the assigned projects.
- Participate in the Benefit Risk Assessment and risk identification, assessment and mitigation activities for assigned projects.
- Review aggregated adverse event reports for signal detection, evaluation and management purposes for assigned projects.
- Review of protocols, study reports, IDMC charters, and operational activities associated with appropriate data provision and presentation of material.
- Assist in the design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.
- Contribute and potentially 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.
- Ability to perform accurately with attention to detail.
- Methodical and analytical approach to work.
- Capable of managing crisis, monitor safety issues and work under pressure.
- Able to prioritise activities and to meet multiple deadlines, setting high performance standards for quality.
- Able to use initiative and creativity in performing task and responsibilities.
- Experience using scientific and clinical databases.
- Bachelors level or above degree in a biomedical or health care-related specialty.
- 2-3 years clinical safety experience or equivalent.
- understanding of safety evaluation methodology/process awareness of pharmacovigilance regulations and methodologies.
- Experience in drafting responses to ad hoc queries or evaluating significant safety issues for regulatory submissions (e.g., PSURs ) under supervision.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.