Hays Specialist Recruitment
PV Officer
Cambridge, United Kingdom, GB - Pharmaceuticals
PVG Officer
FTC 12 months
Introduction
This role will focus on all aspect of case processing within the Pharmacovigilance team for clinical and post marketing. Lastly, to make sure that they are comply with regulations and guidelines.
Responsibilities
* To perform triage of the received messages
* To process Individual Case Safety Reports (ICSRs), including literature reports
* To follow-up and carry out ICSRs to regulatory reporting
* To perform expedited reporting (including electronic reporting) and periodic reporting
* To archive all ICSR documentation
* To produce line listings and summary tabulations
* To support writing or contribute to PSURs and ASRs as required
* To assist with pharmacovigilance processes
* Supporting the Pharmacovigilance teams and representing the Pharmacovigilance at external events
* Maintaining full knowledge of all relevant Pharmacovigilance legislation, guidelines and directives
* Organising and conducting training and mentoring and coaching to new Pharmacovigilance professional within the department.
⢠Assisting in the Audits/Inspections
Have responsible for Pharmacovigilance system related projects
Requirements
Strong have a Bsc at least or relevant experience
Strong Pharmacovigilance background
Strong knowledge of Pharmacovigilance regulations and guidelines
Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation
Knowledge of medical and drug terminology
Understanding of drug development process
Education
BSc degree in a scientific discipline
If this position is of interest to you and would like a more detailed job specification please send an updated CV to gemma.stapleton@hays.com or alternatively call me on +44 (0)203 465 0079 for a confidential discussion.
No salary provided
Posted March 25, 2015 at 04:13PM from LinkedIn http://ift.tt/1BqBd7A
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