Drug Safety Associate

Found in: beBee S PH - 3 weeks ago

Makati City, Philippines Parexel Full time
Job Description

Key Accountabilities:

Drug Safety Support:

Assist in development of project specific safety procedures, workflows and templateAssist in project specific safety database setup, development of data entry guidelines, and user acceptance testingTriage incoming reports for completeness, legibility, and validityElectronic documentation and quality control of drug safety informationData entry of case reports into safety database / tracking systemRequest follow-up and perform query managementCoding of data in the safety databaseWriting case narrativesCreate and maintain project specific working files, case report files and project central filesAssist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as requiredInform 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 projectsSupport of Medical Directors/Safety Physicians, as needed, in medical monitoring activitiesParticipate in client and investigator meetings as requiredAttend internal, drug safety and project specific training sessionsPerform literature searchesPreparation for, participation in, and follow up on audits and inspectionsDelegate work as appropriate to Drug Safety AssistantsAssistance in development of Expedited Reporting ProceduresAssistance with registration with relevant authorities for electronic reporting on behalf of sponsorAssistance 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 ISISTracking and filing of submission cases as requiredAssist with unblinding of SUSARs, as requiredSupport collection and review of metrics for measuring reporting compliance

Skills:

Analytical and problem-solving skillsAble to perform database/literature searchesExcellent interpersonal skillsExcellent verbal / written communication skillsExcellent organizational and prioritization skillsAbility to work collaboratively and effectively in a team environmentClient focused approach to workExperience with computer applications


Knowledge and Experience:

Related experience gained in a healthcare environment is an advantage


Education:

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

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