Company DescriptionArtech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job DescriptionPerforms medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of the line listings of single cases and preparation of investigator notifications.Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal detection monitoring and evaluation based on single cases, aggregate data and signal detection tools, i.e. EMPIRICAPrepares clinical expert statements and provides input in responses to inquiries from regulatory authorities or healthcare professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issuesProvides Pharmacovigilance input to initial development of basic prescribing information and is responsible for Pharmacovigilance input into updates of this informationPrepares medical input to aggregate clinical safety regulatory reportsProvide input to safety profiling and risk management planProvide guidance as appropriate to Clinical Safety Operations for the coding and causality/expectedness assessment of adverse event reportsProvide expert evaluation on the clinical context of adverse event report, assessment on the medical conditions and the implications on Client drugsCollaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departmentsProvides relevant input for internal and external boars and expert panels as well as internal management teams as SPT, SMT, GPT as needed.Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.Skills:3 years Specific Pharma Industry experience requiredQualificationsMD Additional InformationFor more information, please contactAkriti Gupta(973) 967-3409Morristown, NJ 07960 SummaryType: ContractFunction: ManagementExperience level: Mid-Senior LevelIndustry: Pharmaceuticals
...development Competitive salary Flexible schedule Window Cleaning Technician (Full-Time & Part-Time) Fish Window Cleaning is... ...experience in professional window cleaning . Experience with commercial and residential window cleaning, ladder work, and working at...
...ClinDCast is looking for an Epic Orders Analyst for one of its reputed clients. It is a 100% remote opportunity. For this role you must have a passion for healthcare data and technology and you appreciate how health informatics can benefit an organization as a whole. You...
...Community Description: Year-round outdoor activities include golfing, hunting, fishing, camping, hiking, boating Excellent... ...schools Excellent family community, great sports, humble people, top schools, no state income tax! 2 country clubs, 6...
...Growth Partners in Juneau, AK is seeking a part-time Real Estate Appraiser to own end-to-end responsibilities, with a compensation range of $58,000 to $92,000 annually and a flexible schedule. The role emphasizes collaboration, ongoing learning, and the ability to explain...
Hourly Wage: $17.5 - $30.5 per/hour *The actual hourly rate will equal or exceed the required minimum wage applicable to the job location. Additional compensation includes annual or quarterly performance incentives. Additional compensation in the form of premiums...