Job Description

The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

Key Accountabilities

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Drug Safety Support

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Assist in development of project specific safety procedures, workflows and template Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing Triage incoming reports for completeness, legibility, and validity Electronic documentation and quality control of drug safety information Data entry of case reports into safety database / tracking system Request follow-up and perform query management Coding of data in the safety database Writing case narratives Create and maintain project specific working files, case report files and project central files Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities Participate in client and investigator meetings as required Attend internal, drug safety and project specific training sessions Perform literature searches Preparation for, participation in, and follow up on audits and inspections Delegate work as appropriate to Drug Safety Assistants Assistance in development of Expedited Reporting Procedures Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy) Submission of safety reports to investigators via ISIS (International Safety Information System) Assist with measuring investigative site performance in conducting required tasks in ISIS Tracking and filing of submission cases as required Assist with unblinding of SUSARs, as required Support collection and review of metrics for measuring reporting compliance

Skills

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Analytical and problem-solving skills Able to perform database/literature searches Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Experience with computer applications

Knowledge and Experience

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Related experience gained in a healthcare environment is an advantage minimum 1+ years of relevant experience in PV.
Experience in PV database like LSMV (LifeSphere Multivigilance) is preferred.

Education

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Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience * Associates degree in any of the above with appropriate work experience