DescriptionThe Pharmacovigilance Specialist will be responsible for ensuring the operational delivery of assigned tasks at the project level, with a focus on safety case reporting, processing of safety case report data, and literature screening activities. The role involves communication with the Pharmacovigilance Team Leader and Pharmacovigilance Manager regarding potential risks related to operational delivery, quality standards, client relationships, and the company's reputation, as well as addressing ad hoc project tasks and requirements.Position is full-time remote/home-based in any EU country.Responsibilities:
Oversee and manage the workflow of safety case reports, ensuring efficient processingPerform triage on safety case reports to assess priority and necessary actionsReview, manage, and file source documentation in compliance with regulatory requirementsProcess safety case reports, including SDB data entry, narrative writing, seriousness assessment, medical review (including causality and expectedness assessments), and reporting requirements evaluationConduct follow-up activities and manage queries related to safety case reportsExecute quality control checks on data entry and case processing to ensure accuracy and complianceReconcile safety case reports to ensure consistency and completeness of dataPrepare line listings to summarize and report on safety case data RequirementsUniversity degree in Life Science fieldAt least 1 year of experience in Safety and Pharmacovigilance within the pharmaceutical or Contract Research Organization (CRO) industryProficiency in both verbal and written local language and EnglishStrong expertise with MS OfficeBeneficial experience with Veeva Vault Safety systemKnowledge of EU GVP modules and applicable global safety regulations (e.g. ICH, FDA reporting requirements) BenefitsProfessional growth and career opportunitiesInternational team and environmentBonus based on monthly case numbers