Clinical Safety Scientist
Clinical Life Sciences Pharmaceuticals
CY Partners are currently looking for a Clinical Safety Scientist to join a leading global pharmaceutical company, based at their site in Uxbridge.
As a Clinical Safety Scientist, you will be working as part of a global team Supporting 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. As a Clinical Safety Scientist, you will be responsible for supporting the discussion and management of safety issues through matrix teams across the global organisation. You will also be responsible for ensuring that all 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.
Additional skills which would be desirable for this role include the following:
• 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.
This position is offered on an initial contract basis and is an excellent opportunity for a Clinical Safety Scientist to expand on their experience and work with a global company.
For further information please feel free to contact Helen or at CY Partners on 0191 477 4733 or [email protected]