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2020.06.23. | Budapest

Medical Reviewer

Introduction

If you:

  • have medical degree
  • have minimum 1 year experience in the field of pharmacovigilance or clinical
  • have Basic Medical Advisor training

~Knowledge of: 

  • pharmacovigilance practices
  • drug safety & clinical development and ICH/GCP principles

Do not hesitate to apply! 

Tasks
  • Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR)
  • Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database.
  • Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database:

                        - Review and respond to any queries/comments from the Case Owner, which are                                      recorded in the Comment field of the GSP Review Workflow step in the Patient Safety                            database.

                        - Detail any requests for changes to the case, including the narrative and also detail any                            follow-up information that is required and not already noted within the Query Manager                              in the Patient Safety database.

  • Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR).
  • Review :

                        - the medical sense including seriousness and coding of the case in the global context                              of  the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs,                                concomitant medications, laboratory data, and medical history.

                        - the company causality assessment provided by Medical Advisor.

  • Provide documentation of the review and case comments in Sapphire in Medical Review workflow.
  • Ensure compliance with global and local procedural documents and local implementation of client specific policies, procedures and processes.
  • Maintain knowledge of the :

                         - company disease and therapeutic areas for marketed drugs and drugs in                                                 development through periodic medical review training held by AZ medical staff.
                           marketed drug currently under litigation.

Employer's offer
  • Full time Home Office
  • Exposure to work with one of the biggest pharmaceutical companies in the world and support them in development of new medicine
  • Continuous professional growth 
  • Language courses