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Drug Safety Specialist

Eingestellt von Aerotek

Gesuchte Skills: Marketing, Affiliate


Drug Safety Specialist - Cambridgeshire - 12 month contract

This is an exciting opportunity for a Drug Safety Specialist on a 12 month contract with a global pharmaceutical company based in Cambridgeshire. This individual will be reviewing, extracting and accurately enter Adverse Event data from Individual Case Study Reports from both investigational and post marketing products. This is a rapidly growing company and an excellent time to join the team. This company is very people orientated and has an extremely friendly working environment.

Key Responsibilities
*Sets work priorities and direction with input from Manager
*Review, extract and accurately enter AE data from ICSR reports from both investigational and post marketing products
*Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.
*Review, enter, and verify follow-up information for cases and make accurate determination of significant information
*Performs review of ancillary documentation accompanying ICSR reports and identifies pertinent information for incorporations into the case narrative
*Correctly identify cases requiring targeted follow-up, determine relevant follow-up required and prepare follow-up queries
*Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate
*Will interact with other Drug Safety functional areas to process adverse events efficiently and reliably
*Will liaise with clinical department, affiliate, marketing or contract research organizations as needed on safety data issues (ie, obtaining clarification or follow-up information).
*Meet specific data and quality targets for case handling
*Remain current with case handling SOPs, guidance documents and database technology
*Ensures departmental workflow processes and timelines are followed
*May assist with other projects as necessary (ie, study unblinding, clinical trial reconciliation, etc)
*May identify cases requiring investigator letters and draft investigator letters with minimal supervision from Manager or Sr Safety Specialist

The ideal Drug Safety and Public Health Specialist will have the following:
*Ability to maintain confidentiality (especially on patient records), quality and accuracy
*Understands safety database structures and is familiar with data retrieval tools
*Demonstrates attention to detail, teamwork and initiative
*Must be proficient in email and verbal communication. Proficient in Microsoft Excel, Powerpoint and Word
*Degree in life sciences and proven relevant drug safety experience

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice.


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