ProClinical is currently recruiting for a Drug Safety job on behalf of a top 10 global pharmaceutical company located in the London Area. Our client has a vacancy for a Clinical Safety Scientist, as part of the global organisation of the Chief Scientific and Medical Officer (CSMO), the role-holder will work with the safety team to deliver key safety and Pharmacovigilance (PV) objectives.
- Provide technical support and co-ordination to the Director, Safety, PV & Labelling for the Pharmacovigilance System Master File.
- Provide technical support and co-ordination to the Director, Deputy EU QPPV for the QPPV Office.
- Provide technical support to the safety team to update/develop relevant PV related procedural documents
- Assist the Director, Safety, PV & Labelling to deliver and update the Healthcare Pharmacovigilance System Master File (PSMF)
- Assist the Deputy EU QPPV to organise QPPV Office meetings and work with the QPPV Office Administrator in relation to QPPV Office documentation
- Interface with service provider to collate information for PSMF and QPPV Office
- Assist the PV team to generate and/or maintain control documents (Policies, SOPs, Charters, Agreements, etc.)
- Provide support for safety team members to deliver projects related to safety objectives including safety training and inspection readiness.
Skills and Requirements:
- Science degree
- Medical or related area of specialisation, experience dealing with medical and scientific information in a complex and technical area
- University graduate of a science degree or Masters in a medically related discipline
- Pharmacovigilance and/or regulatory experience
- Exposure to and knowledge of PSMF and QPPV related activities
- Good communication skills including written and verbal communication
- Good IT skills including, but not limited to Word, Excel, Outlook, SharePoint
- Excellent organisation skills and sense of urgency/working to tight timelines
- Attention to detail
- Ability to navigate complex projects and interact in a matrix environment
- Demonstrated ownership of projects and tasks
- Development and/or implementation of process improvement initiatives
- Have a flexible approach
- Confident in interacting with people in the organisation
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.