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Vacancy details
Vacancy description:
Job Code:
KP1201-132
Job Title:
PV Scientist
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
Clinical Project Manager, Drug Safety
Country:
United Kingdom
Location:
Any Location
Min experience:
2 years
Annual salary:
Negotiable (30000 - 37000 £)
Apply by:
23 Feb 2012
Our very respectable client based in central London is looking for a PVG Scientist to join their team on a permanent basis.
PURPOSE OF ROLE
To process Serious Adverse Event Reports (SAEs) from Clinical Trials
•To identify SUSARs and fulfil regulatory reporting requirements for SUSAR reporting to the relevant Competent Authorities and Ethics Committees
•To contribute to and author Development Safety Update Reports as required
•To assist in ongoing safety evaluation and signal detection
•To assist in review of clinical trial documentation including protocols, investigator brochures and informed consent documentation
•To meet timelines on SAE data exchange with business partners
•To provide PV support and to keep abreast of safety issues on specified trials
•To support SAE-AE reconciliation as required
Development Safety Update Reports
To contribute to and author DSURs as required using SOPs and templates. Training and support will be provided.
Ongoing safety evaluation
To be pharmacovigilance contact on specified trialsTo provide PV support ensuring safety information is shared between PV and the study team and vice versa
To keep abreast of safety issues on trials
To review AE listings to identify data issues and safety trends as required
To run queries on the ARISg database as required
Qualifications and Experience
Essentials
•Biological Sciences degree or equivalent nursing qualification/ experience.
•At least 2 years experience in a Pharmacovigilance role
•Experience of working in clinical trials
•Working knowledge of ICH/GCP, EU legislation and clinical trial methodology.
•Good experience of database entry and manipulation
•Interest in the field of Oncology
•Computer/technical literate including Microsoft Office.
•Experience of working with MedDRA coding dictionary
Desirables
•Experience of working with Aris Global Database
•Experience of early phase oncology clinical trials
•Experience of writing large safety reports e.g. ASRs, DSURs, PSURs
•Experience of study documentation review
Key Personal Qualities
•Excellent planning and organising skills
•Good communication skills, written and oral
•Ability to maintain rigorous adherence to written procedures e.g. SOPs
•Excellent attention to detail
•Accurate and methodical
•Ability to work on own initiative at times
•Ability to influence and negotiate
•Good written and spoken English
•Enthusiastic and motivated
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