Pharmacovigilance Specialist (Case Processing)

University degree in Life Science field At least 1 year of experience in Safety and Pharmacovigilance within the pharmaceutical or Contract Research Organization (CRO) industry Proficiency in both verbal and written local language and English Strong expertise with MS Office Beneficial experience with Veeva Vault Safety system Knowledge of EU GVP modules and applicable global safety regulations (e.g. ICH, FDA reporting requirements)

Oversee and manage the workflow of safety case reports, ensuring efficient processing Perform triage on safety case reports to assess priority and necessary actions Review, manage, and file source documentation in compliance with regulatory requirements Process safety case reports, including SDB data entry, narrative writing, seriousness assessment, medical review (including causality and expectedness assessments), and reporting requirements evaluation Conduct follow-up activities and manage queries related to safety case reports Execute quality control checks on data entry and case processing to ensure accuracy and compliance Reconcile safety case reports to ensure consistency and completeness of data Prepare line listings to summarize and report on safety case data