Drug Safety Manager - Senior

MSI Group Limited
05 Oct 2017
02 Nov 2017
Contract Type
Full Time
One of our large pharmaceutical clients are actively searching for a Senior Drug Safety Manager who will supervise the collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting and other potential sources. Key Responsibilities: - Act on behalf of the LSO in periods of their absence - 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. - Manage the local PV / Drug Safety team members providing coaching and feedback Education/Skills Requirements: - Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable. - 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 Pharmacovigilance, PV, GMS Database Systems, Pharmaceutical, Drug Safety, Drug Safety Manager
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