Tech Talents
S & P Associate
Tech Talents, Bethesda, Maryland, us, 20811
Share this job as a link in your status update to LinkedIn.Job TitleS & P AssociateLocationBethesda, MD 20817 US (Primary)
CategoryDrug SafetyJob TypeFull-TimeEducationBachelor's DegreeTravelNoneJob DescriptionManage and process all SAEs as per project specific instructionsDocument Control: maintain electronic files for department, perform file case searches, maintain file room for the department and use department databases to track, manage and control issued documents; assign various tracking numbersTrack and process assigned pharmaceutical and Data Management Center (DMC) queriesAssist in the preparation of contract-required reportsGenerate specified data reports from the safety database as requestedProcess and edit safety narratives for IND and Non-IND Adverse Event (AE) cases as requiredDistribute Safety Information according to project specific requirementsAssist in processing of MedDRA coding tasksPerform QC on AE submissionsJob Requirements
Ability to analyze medical research data, review experimental protocols, and summarize safety dataFamiliarity with medical terminologyMust have excellent attention to detail, verbal and written communication skills.Superior organizational skills and customer service abilities are required.Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.General knowledge of the drug and vaccine development process or clinical trials is a plus.We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.#J-18808-Ljbffr
CategoryDrug SafetyJob TypeFull-TimeEducationBachelor's DegreeTravelNoneJob DescriptionManage and process all SAEs as per project specific instructionsDocument Control: maintain electronic files for department, perform file case searches, maintain file room for the department and use department databases to track, manage and control issued documents; assign various tracking numbersTrack and process assigned pharmaceutical and Data Management Center (DMC) queriesAssist in the preparation of contract-required reportsGenerate specified data reports from the safety database as requestedProcess and edit safety narratives for IND and Non-IND Adverse Event (AE) cases as requiredDistribute Safety Information according to project specific requirementsAssist in processing of MedDRA coding tasksPerform QC on AE submissionsJob Requirements
Ability to analyze medical research data, review experimental protocols, and summarize safety dataFamiliarity with medical terminologyMust have excellent attention to detail, verbal and written communication skills.Superior organizational skills and customer service abilities are required.Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.General knowledge of the drug and vaccine development process or clinical trials is a plus.We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.#J-18808-Ljbffr