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Graduate Pharmacovigilance Associate - 6-month contract
JOB POSITION HAS BEEN FILLED
Posted:
Wed, 1st Aug
Salary:
£25000/annum C£25000 pro rata
Location:
St. Albans
Position:
Temporary
Contact Ref:
1780/3
Graduate Pharmacovigilance Associate to join an expanding company in Hatfield Hertfordshire. The Graduate Pharmacovigilance Associate will be offered a salary in the region of £25000 + benefits. Candidates MUST have some industrial experience of pharmacovigilance and this MUST include MedDRA coding knowledge.
Duties and Responsibilities:
" Evaluate and process ICSRs (Individual Case Study Reports) including duplicate checks MedDRA coding narrative writing and tracking
" Perform quality control and provide feedback on ICSRs
" Assists in the preparation of aggregate safety reports
" Assists in the preparation and maintenance of project specific documents addendums working instructions and other procedural document as required for the project
" Assists in the production of monthly progress reports detailing project activities for submission to client
" Assists in the set-up validation and maintenance of project specific drug safety database schemas (ARISg)
" Participation in internal and external audits and inspections by health authorities
" Assists in the evaluation of weekly literature searches to identify case reports and safety data of interest
" Assist in the production and review of reports to be used for signal detection
" Participation in signal detection meetings
" Liaison with data management groups to ensure data management provided with appropriate reconciliation listing and that amendments to safety database are performed appropriately
" Ensure client and patient confidentiality is maintained
" Maintaining awareness of current and potential guidelines/legislation on Pharmacovigilance and related matters clinical trial guidelines and other relevant topics
Skills and Expertise Required:
" Pharmacovigilance experience - essential
" Knowledge of MedDRA coding - essential
" Ideally a Life Science graduate or Health Care Professional (or equivalent level or experience)
" Basic Understanding of PV Regulations
" Experience of safety database data entry e.G. ARISg
" Demonstrated competency in case handling and narrative writing
" Attention to detail and quality focus
" Team player
" Good written and verbal communication skills
" Proactive approach to work
" Good planning and organisational skills