Drug Safety Manager

Elevate Platform Limited
High Wycombe
24 to 33 GBP (Per Hour)
04 Oct 2017
02 Nov 2017
Contract Type
Full Time
Drug Safety Manager / High Wycombe / 5 Months Contract / 24 to 33 GBP (Per Hour) Management of local Pharmacovigilance (PV) staff. * 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 EDUCATION & EXPERIENCE REQUIREMENTS: * 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 Experience * Demonstrated pharmaceutical industry experience including solid experience in a PV responsibility role Education * Life Science degree or equivalent nursing qualifications The Company Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886. If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
This job was originally posted as www.jobsite.co.uk/job/959248212