Medical Advisor

Tata Consultancy Services

  • Budapest
  • Állandó
  • Teljes munkaidő
  • 14 napja
In your role as a Medical Advisor, you will be entering reports of drug adverse events from post-marketed or clinical study source to the safety database. You will be handling non-serious and serious cases according to regulatory requirements, processing the instructions and standard operational procedures. You will also be resolving queries related to pharmacovigilance activities and individual case reports.FUNCTION
  • Enter reports of drug adverse events from post-marketed or clinical study source to the safety database.
  • Provide medical expertise and judgment throughout the case-handling process with medical review of individual cases.
  • You will handle non-serious and serious cases according to regulatory requirements, process instructions and standard operational procedures.
  • Resolves queries related to pharmacovigilance activities and individual case reports.
  • Adhere to global and local procedural documents.
  • A Medical or Physician Degree.
  • Good knowledge of US and EU pharmacovigilance regulatory requirements.
  • Experience in pharmacovigilance practices concerning signal detection and evaluation.
  • Knowledge of drug safety and clinical development and ICH/GCP principles.
  • The ability to evaluate, interpret and synthesize scientific data.
  • The ability to present and critically discuss clinical data in both internal and external discussions.
  • Possess User-level IT skills.

Profession