Bucharest

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Job Description

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 in Bucharest, Romania

Your role
  • Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
  • Address medical questions regarding the protocol and adverse events
  • Participate in preparing essential study documents
  • Develop and review medical monitoring and safety reporting procedural documents
  • Perform medical review of and follow up on incoming SAE reports including narrative content and queries
  • Oversee the safety reporting to the client and appropriate regulatory agencies
  • Participate in and prepare the medical monitoring/PVG part of audits and corrective action plans
  • Participate in feasibility research and client presentations/bid defense meetings

Qualifications
  • Medical Doctor degree, board certified in Neurology
  • Prior experience as a practicing physician is a plus
  • Prior experience in clinical research and review/interpretation of medical records
  • Experience as a Medical Monitor within Neurology trials
  • Knowledge of the safety review process, medical terminology, coding dictionaries and safety regulatory requirements
  • Full working proficiency in English and Romanian
  • Proficiency with MS Office applications
  • Communication, presentation and analytical skills
  • Problem-solving, team and detail-oriented
Nivel de vechime

Asociat

Tip de angajare

Full-time

Ocupație

Furnizor servicii medicale

Sectoare de activitate

Dispozitive medicale

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