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Senior Drug Safety Manager - 12 month contract

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
Drug Safety Jobs
Country:
United Kingdom
Region:
Buckinghamshire
Contract Type:
Temp / Locum / Contract
Currency:
£
Salary:
30 to 35 per hour
Posted:
13-Jul-18
Recruiter:
Key People
Job Ref:
BBBH23457

My client, a Top 10 Pharma client based in Buckinghamshire, currently seeks an experienced PV Manager to join their team on an initial 12 month contract basis. Within this role you will be responsible for the management of local PV staff.

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 50

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 30

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 20

For further information about this role, or other vacancies within Pharmacovigilance and Drug Safety, please contact Tim Barratt on 01727 817 626 or email tbarratt@keypeople.co.uk

Closing Date:
20/07/2018

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