JOB SUMMARY:

Responsible for medical data review and medical safety case processing and related safety activities.  Performs review of medical data to ensure medical/scientific plausibility and to employ medical assessment and knowledge.  Also, provides medical expertise in assigned trials and standalone safety projects.  Train and mentor team members in medical and safety review activities.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Attend and present Medical Data Review activities during the client Kick Off MeetingWrite Medical Data Review Plan in collaboration with the Medical Monitor and in accordance with the client inputCreate protocol specific Medical Data Review Guide in collaboration with the Medical MonitorParticipate in the internal eCRF review meeting and contribute to the development of eCRFDefine data capture requirements as required throughout the study that are consistent with the protocol and reporting needsContribute to the Data Review PlanProvide requirements and specifications for programming of data listingsCollaborate with Clinical Science and Data Operations teams in the development of Qlik Sense builds and protocol specific customizations for patient profilesParticipate in activities involving risk assessment and measuring the effectiveness of risk minimization measuresProvide medical review of data listings and patient profiles, including but not limited to, adverse events, concomitant medications, medical history, labs, vitals, ECGs, eligibility criteria, efficacy assessments and study specific assessmentsPrepare protocol specific templates for the periodic summary reports for safety data, including the Safety Trend Analysis Report (STAR) or Safety Review Committee slide presentations, in collaboration with the Medical MonitorCompose the STAR report during the study according to scope and timelinesConduct in-stream data trend analysis in support of data quality and integrity including protocol compliance and targeted review of patient dataPrepare periodic MDR summary reports or presentations if requestedMedical review and case assessment of SAEs including assessment and coding of preferred term, medical history, indications of concomitant medications and treatment medications; determination of seriousness, causality, expectedness; narrative review; query generation and follow up of SAE till case closureCompose sponsor comment/summaryCompose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

Medical degree from an accredited, internationally recognized medical school or if in the US, a degree from an accredited Physician Assistant or Nurse Practitioner programRecipient of a medical license from the country or region in which he/she currently resides or previously resided, or if in the US recipient of a license to practice medicine as a physician assistant or nurse practitioner5 years’ experience in the practice of medicine in a clinical or academic setting which may include specialty medical training or fellowshipMinimum of 5 years’ experience in Medical Data Review and Medical Safety Review

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com