Clinical Safety Scientist
An exciting opportunity has arisen for a Clinical Safety Scientist to join the Consumer HealthCare Safety Evaluation and Risk Management group, with a world wide global organisation at their site in Brentford.
This organisation develops and markets brands in the Oral Health, Pain Relief, Wellness and Respiratory and Skin Health categories and they are one of the world’s leading over the counter healthcare companies. Their strategy is to meet the everyday healthcare needs of our consumers through building consumer preferred and expert-recommended brands, differentiated by science and insight-drive innovation.
Key Responsibilities would include the following:
- In conjunction with the safety physician, performs routine signal detection activities (literature review, individual case awareness and aggregate data review) in order to identify, assess and escalate signals appropriately.
- Conducts, or leads with guidance, the discussion and management of safety issues through matrix teams across the global organisation and the presentation of findings to GSK governance boards.
- Authors regulatory documents (eg. PSURs, renewal documents, risk management plans, submission documents) according to agreed timelines and processes.
- Contributes to labelling updates by preparing documentation and presenting to relevant boards.
- Provides safety expertise into innovation projects and contributes to due diligence activities.
- Contributes to advancement of methodology and fit for purpose process improvements.
Experience of end to end authoring of periodic reports, signal detection, safety evaluation and/or risk management experience is highly desirable for this opportunity.
To find out more or to apply, please contact Helen Tomlinson at CY Partners on 07851246847 or submit your CV to [email protected]