Clinical Safety Scientist
An exciting opportunity has arisen for a Clinical Safety Scientist to join GSK’s Consumer HealthCare Safety Evaluation and Risk Management (SERM) group. GSK’s Consumer Healthcare business develops and markets brands in the Oral Health, Pain Relief, Wellness and Respiratory and Skin Health categories. We are one of the world’s leading over the counter healthcare companies and our 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.
- BSc Biomedical Science / Pharmacy degree (or equivalent), or above
- Background in pharmacovigilance
- Experience in Signal detection and authoring periodic reports
- An awareness of international pharmacovigilance requirements and the drug development/approval process
- Experience of consumer healthcare products eg. OTC medicines, cosmetics, medical devices
- Attention to detail and the ability to work effectively in a dynamic environment characterised by tight timelines and changing priorities
- Highly effective oral and written communication skills