Senior Medical Data Analyst and Patient Safety Expert

Há 3 dias

São Paulo, São Paulo, Brasil beBeeMedicalDataReviewPhysician Tempo inteiro R$147.281 - R$245.942

Job Summary:

We are seeking a Medical Data and Safety Review Physician to join our team of medical professionals.

The ideal candidate will have a strong background in medicine, with experience in medical data review and medical safety case processing. They will be responsible for reviewing medical data to ensure medical/scientific plausibility and employing medical assessment and knowledge.

The selected candidate will provide medical expertise in assigned trials and standalone safety projects, train and mentor team members in medical and safety review activities, and participate in internal eCRF review meetings and contribute to the development of eCRF.

Responsibilities:

  • Attend and present Medical Data Review activities during client Kick Off Meetings
  • Develop Medical Data Review Plans in collaboration with the Medical Monitor and according to client input
  • Create protocol-specific Medical Data Review Guides in collaboration with the Medical Monitor
  • Participate in internal eCRF review meetings and contribute to the development of eCRF
  • Define data capture requirements throughout the study that are consistent with the protocol and reporting needs
  • Contribute to the Data Review Plan
  • Provide requirements and specifications for programming of data listings
  • Collaborate with Clinical Science and Data Operations teams in the development of Qlik Sense builds and protocol-specific customizations for patient profiles
  • Participate in activities involving risk assessment and measuring the effectiveness of risk minimization measures
  • Provide medical review of data listings and patient profiles, including adverse events, concomitant medications, medical history, labs, vitals, ECGs, eligibility criteria, efficacy assessments, and study-specific assessments
  • Prepare protocol-specific templates for periodic summary reports for safety data, including the Safety Trend Analysis Report (STAR) or Safety Review Committee slide presentations, in collaboration with the Medical Monitor
  • Compose the STAR report during the study according to scope and timelines
  • Conduct in-stream data trend analysis in support of data quality and integrity, including protocol compliance and targeted review of patient data
  • Prepare periodic MDR summary reports or presentations if requested
  • Perform medical 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 closure
  • Compose sponsor comment/summary
  • Edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements

Requirements:

Medical degree from an accredited, internationally recognized medical school or a degree from an accredited Physician Assistant or Nurse Practitioner program

Medical license from the country or region in which he/she currently resides or previously resided, or a license to practice medicine as a physician assistant or nurse practitioner

5 years' experience in the practice of medicine in a clinical or academic setting, which may include specialty medical training or fellowship

Minimum of 5 years' experience in Medical Data Review and Medical Safety Review

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