Provide medical experitise on pharmacovigilance services to all Quintiles divisions as requested. The Medical Safety Advisor participates in all aspects of Medical involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.
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
Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported rofile
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