Clinical Safety Scientist
- Uxbridge, (GBR)
- £75 - £80 Per Hour
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00078007
- clinical safety
- processing
- mapping
Description:
Are you looking for a Clinical Safety Scientist role or aspire to be one?
Do you want a role which will allow you to contribute positively to not only your community but the world?
Come and join us! Together we can serve the patients around the world to do more, feel better and live longer!
Who are we?
At GSK we are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines, and Consumer Healthcare. Our mission is inspiring and challenging – to help people do more, feel better and live longer.
We have a significant global presence with commercial operations in more than 150 countries, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium, and China.
Basic qualifications:
Bachelors degree in Biomedical or Health Care related speciality
Capabilities and prior experience:
PhD or other higher degree may be advantageous
Excellent capability in managing a fast paced, changing environment. A strong self-starter who can rapidly integrate independently into busy project areas.
Experience in data gathering, data synthesis, analysis and interpretation.
Strong medical/scientific writing skills including experience authoring regulatory documents (e.g. DSURs and PBRERs)
Knowledge of relevant pharmacovigilance regulations and methodologies
Knowledge and experience of the principles of causality assessment and the evaluation of safety signals.
Good capability in drug development and approval process.
Experience in post marketing pharmacovigilance activities.
THE ROLE
• Support the proactive monitoring and evaluation of all aspects of the safety profile of designated products and ensure that optimal decisions are made at all stages of the product lifecycle.
• Support the discussion and management of safety issues through matrix teams across the global organisation.
• Ensure that safety documents (e.g. periodic reports, signal evaluations, labelling documents, regulatory enquiries, risk management plans) are written accurately and in a timely manner to meet global compliance and regulatory requirements.
To be successful you will be able to demonstrate the following:
• The ability to influence with credibility both externally as well as at all levels of a matrix organisation.
• Good decision making and problem resolution based on all relevant information.
• Strategic thinking, recognising key issues and providing practical solutions.
• Analytical thinking, with proven ability to analyse clinical safety and scientific data, whilst applying sound judgment.
• Highly effective communication skills and the ability to present complex data/information at all levels of the organisation and externally to GSK.
• Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities.
• The ability to leverage pharmacovigilance expertise across a range of therapy areas and stages of clinical development as the need arises.
• Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills.
• An awareness of international pharmacovigilance requirements (e.g. ICH, EU pharmacovigilance regulations, and CIOMS initiatives) and the drug development and approval process in major countries.
• Knowledge of other relevant disciplines (e.g. statistics, pharmacoepidemiology) pertinent to safety at the population level.
All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.
