Drug Safety Manager

Real Staffing
High Wycombe
£30 - £34 p hour + competitive
04 Oct 2017
02 Nov 2017
Contract Type
Full Time
I have an amazing opportunity I have at the moment for an experienced Drug Safety Manager within the Pharmaceutical industry in High Wycombe and thought the below opportunity might be of interest to yourself. This is a great chance for you to work in an exciting whilst gaining valuable experience within a highly regulated environment, which I'm sure would be a good addition to your CV. You would be working with a fantastic global Pharmaceutical company based in High Wycombe. They're looking for a Drug Safety Manager and the rate is up to £34 per hour. It is a 6 month contract role that does offer high opportunity of progression. As a Drug Safety Manager you will be responsible for Job Description: Role Purpose: - Safety Management and Reporting - Act on behalf of the LSO in periods of their absence - Supervise the collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study reports, local literature, and all other potential sources - Conduct initial quality review and assessment of local individual cases - Write, review, validate and implement the (local) operating procedures/guidelines and verify adherence - Manage and maintain active involvement in day-to-day AE reporting - Co-ordinate the follow-up of missing information in safety cases and undertake site visits for follow-up of local cases of special interest - Provide local data as required to support the preparation of Safety Summary reports (PSUR, DSUR, etc.) Required Skills: - Demonstrated pharmaceutical industry experience including solid experience in a PV responsibility role - Proven ability to organise workflow activities and manage multiple critical issues - Awareness of and familiarity with industry principles of pharmacovigilance, drug development and pharmacology - Sound knowledge of Global and Local SOPs - Sound knowledge of GMS database systems - Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers - Ability to establish and maintain open relationships within the organisation and with authorities - Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety Education - Life Science degree or equivalent nursing qualifications Related Experience: 3 to 5 years If you're interested and are looking to more into a managerial role and have previous line management experience or you'd like to find out more information then please don't hesitate to get in touch! To find out more about Real please visit ******************** Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
This job was originally posted as www.jobsite.co.uk/job/959254923