Medical Safety Advisor
IQVIA
Buenos Aires, AR
hace 33 días

Job Description

Join us on our exciting journey!IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.

Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

PURPOSE

Provide medical experitise on pharmacovigilance services to all Quintiles divisions as requested. The Medical Safety Advisor participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.

RESPONSIBILITIES

  • Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
  • Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
  • Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
  • Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
  • Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
  • Represent safety and clinical data review findings during client meetings
  • Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract
  • Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and / or Case Report Forms (CRFs) for appropriate safety content and data capture.
  • Act as Global Safety Physician or Assistant or Back-up on projects as assigned
  • Attend project meetings, medical safety team meetings, and client meetings as requested
  • Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
  • Provide medical escalation support for medical information projects
  • Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
  • 24 hour medical support as required on assigned projects
  • Maintain awareness of medical-safety-regulatory industry developments
  • All responsibilities are essential job functions unless noted as nonessential (N).

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