Drug Safety Specialist (Reporting)

The Drug Safety Specialist 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).Quality control of case reports, line listings, and tabulationsPerform literature searchesDevelop Expedited Reporting ProceduresMaintain local drug safety reporting requirementsProvide advice in regulatory affairsPerform registration with relevant authorities for electronic reporting onbehalf of sponsorPerform setup and deployment of worldwide reporting as required toregulatory authorities, CECs, localECs, and investigator sites (electronic and hard copy)Submission of periodic safety reports (i.e. DSUR, ASR)Submission of safety reports to investigators via ISIS (International SafetyInformation System)Measure investigative site performance in conducting required tasks in ISISTracking and filing of submission cases as requiredUnblinding of SUSARs, as requiredCollect and review metrics for measuring reporting complianceWork with Global PV Information Office for collection and organization of global PV requirementsQualificationsSkills: Sound knowledge of drug safety and the drug development processKnowledge of and ability to interpret and apply global safety regulationsExperience in data analysis and evaluation of safety dataGood presentation skillsAnalytical and problem solving skillsClear understanding of the regulatory submission processProficient in 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 including database management and pharmacovigilance systems

Knowledge and Experience: Drug safety knowledge and experience

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