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Psychiatry Advisor
hace 1 semana
This Psychiatry Advisor role at IQVIA will provide medical, clinical, and scientific advisory expertise to all divisions as requested. Participate in all aspects of Medical Science involvement on assigned trials, serving as a medical expert during the project delivery life-cycle. Your primary responsibility will be to provide therapeutic medical and strategic expertise to business development activities.
Main Responsibilities:
* Serve as Global and Regional Medical Advisor on assigned projects.
* Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects.
* Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
* Conduct medical reviews of protocols, Investigative Drug Brochures (IDBs), and Case Report Forms (CRFs).
* Provide therapeutic area/indication training for project clinical teams.
* Attend and present at Investigator Meetings.
* Perform review and clarification of trial-related Adverse Events (AEs).
* May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
* May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of the Pharmacovigilance department.
* May perform medical review of adverse event coding.
* Review the Clinical Study Report (CSR) and patient narratives.
* Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
* Available 24 hours a day, 7 days a week to respond to urgent protocol-related issues at the investigative sites.
Requirements:
* Excellent communication, presentation, and interpersonal skills, including command of the English language (both written and spoken).
* Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
* Certification as a Psychiatrist (mandatory).
* 3 - 5 years of prior relevant experience in general clinical medicine.
* Previous clinical research experience as an investigator or in the Pharma, CRO, or Biotech industry is required; or equivalent combination of education, training, and experience.
* Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
* Strong Business Acumen.
* Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
* Excellent skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.