Duration: 12 Months Contract (Potential temp to perm) Pay Rate : $19/hr. - $26/hr. Shift Time: 1st shift, M-F (8:30 AM -5 PM) Job Description: The incumbent is required to be an independent contributor that efficiently and effectively accomplishes drug safety tasks and deliverables with little oversight. Prefer if they have ARGUS/safety database experience. As Global Drug Safety team member, DSC obtains and processes all appropriate information regarding adverse event data to maintain a thorough and strict adherence to Good Clinical Practices (GCP), regulatory guidelines, and company SOPs. Assists Drug Safety Scientist (DSS) and management in building team environment among assigned staff and between other departments. Primary responsibilities Identify, track, and file potential adverse event (AE) information. Responsible for monitoring all incoming information and identification of potential AE information and assembling data for team meetings. Enter the report into the tracking log, check whether it is an initial, a follow-up, or a duplicate report and creates a case folder. Identify and delete all confidential patient information from the source documents received. Record protocol number and site/patient number, if applicable, on all source documents. Provide the report to the conducting case owner Identify, track, and file potential adverse event (AE) information. Additional responsibilities The Drug Safety Coordinator is the first person in Global Pharmacovigilance to review the source documents for AE reports. As such, the DSC makes the first determination of report completeness and the need to perform follow-up with the reporter. Maintains a basic understanding of the protocol and scope of work for clinical studies. Maintains a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations. Responsible for management of receipt, review and filing of literature sources that may contain AE information. Knowledge, Skills, and Abilities Excellent technical skills required, including the ability to comprehend and integrate scientific data from a variety of sources. Comprehensive knowledge of medical terminology required. Excellent interpersonal, organizational, and prioritization skills. Flexibility and the ability to multitask is mandatory. Requirements 2-3 years of recent experience in a clinical setting or equivalent in experience or training. Clinical drug development experience preferred. #J-18808-Ljbffr
...Required: None Job Family: Intelligence Operations and Analysis Job... ...mission outcomes as a Tactical All Source Threat Intelligence Analyst 2 at GDIT. Here, you'll enable the success... ...'s mission. ***Candidates MUST be open to working 8 pm to 6 am, on either a...
Starlight City Pictures seeks US-based film directors to develop and direct upcoming short films from New York. We welcome filmmakers with strong pacing, character development, atmosphere, and vision to join our indie slate.Directors receive a fixed stipend per film,...
...Job Description Job Description We are seeking a Psychiatric-Mental Health Nurse Practitioner to provide individual psychiatric care in an outpatient clinic serving adults, children, and adolescents. The role emphasizes in-person and telepsychiatry services, including...
Maintenance Electrician Stockton, CA Compensation Includes ~ Starting pay rate of $37.44/hour Available Shift ~2nd: 3pm - 11pm, Monday - Friday with Saturdays as needed ~3rd: 11pm - 7am, Monday - Friday with Saturdays as needed ~ Must be available...
...and your work helps build a better world. Ready to shape the future of resilient communities? Verdantas is seeking a part-time Senior UI/UX Project Designer to join our team in Annapolis Junction, MD, Washington, DC, or Reston, VA. In this role, you will design cohesive,...