[Position] Pharmacovigilance (MI) Specialist / Regulatory Affairs
• Responsible for data entry of all types of individual case safety reports and daily mgmt. of cases and reporting of issues
• Responsible for monitoring the safety mailbox
• Responsible for updating of defined working instructions & guidelines and SOPs
• Responsible for the certificate process including regulatory submission processes proces
• Coordination and compilation of documentation for clinical trial applications, new applications and renewals
• Coordination and facilitation of Change Requests (CR) including CR-mailbox ensuring distribution, reassignment and finalisation.
• Liason with external experts and M&S RAMs and interaction with production sites
• Data entry in the Regulatory and PV database and document handling
•Pharmacist, BSc / Master in Pharmacy Life Science
• Fluency in English
• + 2 (~ 8) years experiences from PV/Regulatory area
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