Company: ProClinical Ltd
Closing Date: 27 Oct 16
Salary (£): Competitive
A well-known international pharmaceutical company with sites around the globe is looking to hire a Drug Safety Officer. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology. Role OverviewReview, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of the clients products and to meet regulatory requirements. ...
A well-known international pharmaceutical company with sites around the globe is looking to hire a Drug Safety Officer. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology.
Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of the clients products and to meet regulatory requirements. Determination of submission reports also aggregated
Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
Review, rank, verify, process and document: event terms; case classifications (validity, seriousness) special scenarios; product complaint information; report ability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
Review case criteria to determine the appropriate workflow for case processing.
Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
Write and edit the case narrative.
Determine and perform appropriate case follow-up, generating follow-up letters
Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation
Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
Determine report ability of scheduled reports, ensuring adherence to regulatory requirements
Consistently apply regulatory requirements and company policies
Ability, with supervision, to solve routine problems and to surface issues constructively
Ability to make basic decisions with an understanding of the consequences
Demonstrated computer literacy, particularly in the use and management of relational databases
Ability to achieve personal objectives while meeting departmental standards of performance
Ability to work under supervision in a matrix organization
Experience and skill with medical writing an advantage
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Lisa Edgar on 0203 7520 313 or upload your CV on our website www.proclinical.com. A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Eldon House Eldon Street London
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