Medical Officer
PSI
Bucharest, Romania
5 zile în urmă

PSI Medical Officers provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-

being. Join our group of medical professionals, build a career on the frontline of medical science, and use your knowledge and expertise to help bring new medications to patients that need them.

Office-based or Home-Based

Your role :

  • Provide medical monitoring to clinical project teams and sites including out of hours coverage
  • Collaborate with Project Management, Clinical Operatios and other departments in the preparation of clinical development plans, protocols, investigator brochures, clinical study reports
  • Responsible for review and analysis of clinical data including safety monitoring
  • Provide medical training to the project teams and sites
  • Perform medical review of and follow up on incoming SAE reports including narrative content and queries
  • Participate in BID defense, Kick-off meetings, Investigator's Meetings (prepare and deliver presentations)
  • Participate in project risk assessment activities
  • Qualifications

  • Medical Doctor degree, board certified in Internal Medicine / Gastroenterology is a plus
  • Prior experience in medical practice / patient care
  • Prior experience in clinical research and review / interpretation of medical records
  • Knowledge of the safety review process, medical terminology, coding dictionaries and safety regulatory requirements
  • Strong knowledge and experience with Internal Medicine / Gastroenterology trials
  • Full working proficiency in English and Romanian
  • Proficiency with MS Office applications
  • Communication, presentation and analytical skills
  • Problem-solving, team and detail-oriented
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