Biomapas
Teams at Biomapas
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Healthtech • Biotech • Pharmaceutical
Supports global and local pharmacovigilance systems, ensuring regulatory compliance across pre- and post-authorization activities. Manages PV projects, SOP updates, KPI reporting, case processing, safety reports, risk management plans, customer communications, audits, inspections, and health authority interactions. May serve as EU QPPV or deputy QPPV and contribute to forecasting and budget planning.
Healthtech • Biotech • Pharmaceutical
Leads global Central Pharmacovigilance Services, overseeing case processing, literature surveillance, signal detection, benefit-risk management, aggregate reporting, compliance, quality, and operational excellence. Builds scalable delivery hubs and outsourcing models, drives automation and AI adoption, manages KPIs and financial performance, supports audits and inspections, and partners with clients and cross-functional teams. Develops the leadership organization, succession planning, and global workforce capabilities while ensuring compliance with EU, FDA, ICH, and other pharmacovigilance regulations.
Healthtech • Biotech • Pharmaceutical
Responsible for local pharmacovigilance activities across the DACH region, including safety information processing, regulatory compliance, health authority and client communication, literature monitoring, audits and inspections, SOP development, medical information request handling, and PV training. The role serves as a local safety contact and supports quality standards for regional pharmacovigilance operations.