Data Officer

Job Description

Responsibilities:

• Data entry of vigilance cases in the relevant databases
• Preparation of initial email (in the context of follow up request), requests for clarification
• Submission of cases to the competent authorities
• Carrying out specific queries in the databases in order to draft reports
• Monitoring and downloading ICSRs in the national databases (Eudravigilance, MHRA portal)
• Recordings/updates on XEVMPD
• Drafting/updating of technical agreements /safety management plan /client template
• Drafting/updating of SOPs/WPDs/Trainings others documents directly related to their activity
• Participation in the implementation/maintenance/improvement of processes

Education and Experience:

• Bachelors degree in science/ Industrial Biology/Chemistry Engineer
• Min 2 years experience in pharmacovigilance working for service providers performing data entry and QC of cases
• Previous experience working to deadlines.
• Client communications
• Knowledge of US and EU PV regulations
• Pharmaceutical background strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
• Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment

Are you interested in this position?
Apply by clicking on the “Apply Now” button below!
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