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.
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.
- 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
- 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