Drug Safety Manager

Juice Resource Solutions
United Kingdom
£30-£34 p.h.
05 Oct 2017
07 Nov 2017
Contract Type
Full Time
Drug Safety/Senior Drug Safety Manager Global Pharmaceutical Company ASAP Start Rate: up to GBP 34p.h. Location: Greater London KEY ACCOUNTABILITIES: 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.) * Where applicable, support the Qualified Person (QP) for PV to provide safety-related regulatory communication (e.g. response to request for information from Local HA) * Implement compliance standards and facilitate the collection of compliance metrics as required * Give training on drug safety reporting of LOC personnel and maintain awareness of drug safety reporting in general People Management * Manage the local PV / Drug Safety team members providing coaching and feedback * Work with EMEA PV to provide relevant drug safety input to the PV training plan and assist with the execution of training within the LOC * Direct local safety staff activities, in collaboration with GMS, to ensure that specified timelines and reporting requirements are met Additional Compliance Activities * Complete compliance metrics as required * Sign off memos in TARGET * Review effectiveness of CAPAs * Trend deviations and implement CAPAs as necessary * Support inspection and audits * Support CSTL/LSO in ad hoc requests as required * Contribute to global, regional, local projects ESSENTIAL KNOWLEDGE & SKILLS: * Demonstrated pharmaceutical industry experience including solid experience in a PV responsibility role * Life Science degree or equivalent nursing qualifications * 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 Due to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Juice Resource Solutions within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.
This job was originally posted as www.jobsite.co.uk/job/959259243