Description
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).
Qualifications You should have:
A valid medical license, or equivalent, from the country or region in which he/she resides and works
A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education and 3 years' experience practicing clinical medicine after award of medical degree; or equivalent combination of education, training and experience.
At least 4 years of solid Pharmaceutical / CRO´s experience, preferebly in safety roles
Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
Knowledge of clinical trials and pharmaceutical research process
Ability to establish and meet priorities, deadlines, and objectives.
Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.
Ability to establish and maintain effective working relationships with coworkers, managers and clients
