drjobs Medical Monitor (Hematology)

Medical Monitor (Hematology)

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1 Vacancy
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Job Location drjobs

Sofia - Bulgaria

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners while always focusing on patients safety and wellbeing.

Responsibilities: 

  • Provide medical monitoring to clinical project teams and sites including out of hours coverage
  • Advise clients data safety monitoring boards regulatory agencies and thirdparty vendors on medical matters
  • Collaborate with Project Management Clinical Operations and other departments in the preparation of clinical development plans protocols investigator brochures clinical study reports
  • Review and sign off clinical documents with respect to medical relevance
  • Review and analyze clinical data including safety monitoring
  • Perform medical review of and follow up on incoming SAE reports including narrative content and queries
  • Address safety issues across the study from sites and the study team
  • Provide medical training to the project teams and sites
  •  Participate in BID defense Kickoff meetings Investigators Meetings (prepare and deliver presentations)
  • Participate in project risk assessment activities identify program risks and create and implement mitigation strategies with Clinical Operations

Qualifications :

  • Medical Doctor degree
  • Board certified in Hematology
  • Experience in medical practice/patient care
  • Experience in a similar role is a plus
  • Knowledge of the safety review process medical terminology coding dictionaries and safety regulatory requirements 
  • Strong knowledge of and experience in the area of Hematology
  • Full working proficiency in English
  • Proficiency with MS Office applications
  • Communication presentation and analytical skills
  • Problemsolving team and detailoriented


Additional Information :

As part of PSIs Medical Monitoring team you will join our international 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.


Remote Work :

Yes


Employment Type :

Fulltime

Employment Type

Remote

Company Industry

About Company

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