Medical Reviewer (Budapest)

Medical Reviewer (Budapest)
A hirdetés már lejárt!

 

On behalf of our multinational partner, we are looking for candidates with experience of pharmacovigilance or clinical with a Medical diploma to join one of the biggest Multinational companies.

Medical Reviewer

Tasks

As a Medical Reviewer you will be responsible for the following tasks:

  • 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.
  • 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 company causality assessment provided by Medical Advisor.
  • 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.
  • To 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 marketed drug currently under litigation.
  • 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.
  • Support Medical advisor activity as and when required.

Requirements

  • 1-2 years of experience in clinical or  pharmacovigilance 
  • Knowledge of drug safety & clinical development and ICH/GCP principles
  • Medical degree
  • Knowledge of US and EU pharmacovigilance regulatory requirements is an advantage.
  • Excellent spoken and written English and Hungarian
  • Analytical thinking
  • Customer Orientation
  • Problem solving

Offers

  • opportunity to work with the top 10 Pharma company partner
  • Interesting projects
  • Continuous professional development
  • Remote / home office contract
  • 1 year fixed term contract
  • Options to work Part/Full Time
  • English usage on daily routine

Workplace

Budapest

 

Budapest

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