Drug Safety Associate/Specialist

Parexel International Corporation

USA - Northeast - Home Based

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).

Assist in development of project specific safety procedures, workflows and templatesAssist 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 Services 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 complianceSupport Global Pharmacovigilance Information Office (GPIO) in the collection and organization of global PV requirementsQualificationsSkills:

· 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:

· Related experience gained in a healthcare environment is an advantage


· 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 EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

2021-01-28 01:00:52

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