Drug Safety Manager - Senior

Recruiter
MSI Group Limited
Location
Buckinghamshire
Posted
05 Oct 2017
Closes
02 Nov 2017
Sector
Healthcare
Contract Type
Contract
Hours
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
This job was originally posted as www.jobsite.co.uk/job/959261467