Healthcare Pharmaceutical Diagnostics
The Drug Safety (DS) Scientist works within Drug Safety & Risk Management group. S/he performs pharmacovigilance tasks and prepares submission-ready regulatory documents within agreed time frames and to a high standard of accuracy, in compliance with GE Healthcare business rules, standard operating procedures and global and local regulatory requirements.
The Drug Safety (DS) Scientist will provide scientific support to Drug Safety physicians for safety scientific activities from clinical trials and post-marketing experience.
• Author aggregate safety reports required by health authorities such as, Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), US Periodic Adverse Drug Experience Report (PADER).
• Produce high quality, accurate and fit-for-purpose evaluation documents with clear conclusion, in response to internal or regulatory authority safety-related requests.
• Run accurate queries and provide standard outputs of the data from the safety database; create draft reports/data tables and to perform searches of the safety database for ad-hoc queries.
• Support preparation of RMP and post-marketing safety monitoring activities.
• Review publications from worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports.
• Conduct routine and ad-hoc signal detection and evaluate safety data and signals as part of ongoing pharmacovigilance activities. This includes the ability to summarize data from multiple sources and authoring signal evaluation reports.
• Provide support to the compilation of information for reference safety information (including Company Core Safety Information).
• Participate and contribute to Safety Management Team meetings.
• Support Drug safety physicians in handling issues related to both clinical and post-marketing safety, as needed.
• Perform other duties related to the position as necessary and as defined in SOPs and/or at the request of supervisor.
• Bachelor’s or master’s degree in biologic or natural sciences; or health case discipline.
• Minimum of 2 years of pharmaceutical/biotechnology experience, including clinical trial and post-marketing pharmacovigilance experience. Global experience preferred.
• Ability to summarise and evaluate data, experience with safety database preferred.
• Experience in report writing (e.g. aggregate reports, responses to questions, etc.).
• Knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance.
• Excellent oral and written communication skills (English).
• Excellent computer skills, in particular Microsoft Word and Excel
• Ability to function in an environment of rapidly changing priorities and to manage multiple projects simultaneously while maintaining a high level of quality, accuracy and attention to detail.
• Ability to act independently and to take initiative as well as work within a team. Self-starter, able to work with a high degree of independence.
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