Pharmacovigilance Specialist
São Paulo, São Paulo, Brazil
• Assessment and processing of all types of adverse event reports (spontaneous, clinical trials, medical literature, post-marketing surveillance studies), ensuring medical plausibility, consistency and integrity of data, in compliance with health authority requirements.• Coding of events and medications according to MedDRA and WHO-DD guidelines, including causality, severity and overall expectation analysis, following internal and regulatory procedures.•Requesting additional information and using specific questionnaires related to products/events to ensure the accuracy of causality assessments.• Preparing causality comments on behalf of the company, with clinical and scientific basis.• Acting as a medical consultant for case assessment and causality feedback, offering guidance to new employees and peers.• Conducting training and presentations on medical and pharmacovigilance topics for the team, promoting continuous updating and alignment with the best practices in the sector.• Active participation in auditing and inspection activities, contributing to compliance with quality standards and policies.• Experience in analyzing compliance with adverse event reports, ensuring adherence to regulatory requirements and company expectations.