Clinical Safety Scientist
CY Partners have a range of opportunities for Clinical Safety Scientists across the South of England, working with a world wide global organisation at their site in Brentford.
Key Responsibilities may 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.
To find out more or to apply, please contact Helen Tomlinson at CY Partners on 07851246847 or submit your CV to [email protected]