- have medical degree
- have minimum 1 year experience in the field of pharmacovigilance or clinical
- have Basic Medical Advisor training
- pharmacovigilance practices
- drug safety & clinical development and ICH/GCP principles
Do not hesitate to apply!
- 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.
- 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