Salary description: 28 - 32K
Job Type: Clinical Research
•Support pharmacovigilance activities.
•Set up safety databases.
•Process Serious Adverse Event reports.
•Act as mentor for Pharmacovigilance team members.
•Participate in client liaison.
•Ensure pharmacovigilance data is processed such that subjects’ rights, safety and well being are protected and that the pharmacovigilance data are reliable.
•Ensure that the safety database is set up correctly for each study.
•All aspects of Serious Adverse Event reporting including stakeholder awareness, liaison with the relevant authorities and sponsors, SAE management plans.
•Ensure that the safety data set is available for the Sponsor in the timeframe, format and via the method agreed.
•Review and QCs safety database set up and data entry.
•Work with Data Managers to ensure that the Serious Adverse Event data in safety databases and clinical databases are reconciled on a regular basis.
•Review completed Data Clarification Forms and amends the safety database where appropriate.
•Maintain the cumulative Serious Adverse Event section and the Pharmacovigilance correspondence section of the Trial Master File (TMF).
•Generate and reviews patient narratives.
•Assist in the validation and implementation of upgrades to the PV Works™ safety database, in conjunction with company IT department and the vendor, Assured.
•Participate in company project teams.
•Attend client meetings and liaises with clients where appropriate.
•Assist with the generation and review of SOPs and WPGs.
•Involved in training Pharmacovigilance staff.
The ideal candidate will have a degree or equivalent in a relevant science
or healthcare based subject, a proven track record in the CRO or pharmaceutical
industry including Pharmacovigilance experience, an awareness of the global
regulatory and Pharmacovigilance environment and a good working knowledge
of ICH GCP.
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