UK - Drug Safety Manager - Senior job in United Kingdom, HIGH WYCOMBE

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This Drug Safety Manager job is with one of the most renowned global pharmaceutical, medical device and consumer health organisations located in High Wycombe. The organisation is a top 10 pharma company and employs over 100,000 professionals worldwide.

Job Responsibilities:

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 50
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 30
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 20

Skills and 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
Demonstrated pharmaceutical industry experience including solid experience in a PV responsibility role
Life Science degree or equivalent nursing qualifications
3 to 5 years 1

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Amy Quinn on +44 207 4400 633 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.